Effects of anifrolumab-fnia injection: A Synthesis of Findings from 21 Studies

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Original Abstract of the Article

Major Research Findings

Anastrozole, an aromatase inhibitor, has been shown to be effective in treating early breast cancer in postmenopausal women. 9 Multiple studies have shown that anastrozole can improve disease-free survival compared to tamoxifen, both when used after a period of tamoxifen treatment and as initial therapy. 9 , 4 Anastrozole has also been demonstrated to effectively suppress estrogen production, which is crucial in treating hormone-receptor-positive breast cancer. 3 Furthermore, anastrozole can induce histological changes in tumors, suggesting its impact at a cellular level. 5 Anastrozole has also been studied as a treatment for advanced breast cancer and shows promise in this area. 11 The IMPACT trial demonstrated potential benefits of anastrozole in improving lipid and bone metabolism compared to tamoxifen. 7 Long-term anastrozole therapy has also been shown not to increase the risk of osteoporosis. 21

Benefits and Risks

Benefits Summary

Anastrozole has shown significant benefits in the treatment of early breast cancer in postmenopausal women. It improves disease-free survival compared to tamoxifen, suggesting its effectiveness in preventing cancer recurrence. 9 , 4 It also effectively suppresses estrogen production, which is crucial in treating hormone-receptor-positive breast cancer. 3 Anastrozole demonstrates potential for treating advanced breast cancer as well. 11 The drug can also positively impact lipid and bone metabolism compared to tamoxifen, suggesting additional benefits beyond cancer treatment. 7 Long-term use of anastrozole does not appear to increase the risk of osteoporosis. 21

Risks Summary

While anastrozole offers benefits, it can also have negative impacts. One of the main concerns is its potential to decrease bone mineral density, increasing the risk of fractures. 14 , 21 Some studies suggest that combining anastrozole with tamoxifen might lead to reduced disease-free survival compared to anastrozole alone. 16 Anastrozole can also cause side effects such as joint pain and bone pain. 20 While it might have a lower impact on the endometrium compared to tamoxifen, potential effects on this tissue need to be carefully monitored. 8

Comparison Between Studies

Commonalities Across Studies

Multiple studies consistently demonstrate the effectiveness of anastrozole in treating early breast cancer in postmenopausal women. It shows an improvement in disease-free survival and generally has good tolerability compared to tamoxifen. 9 , 4 , 20

Differences Across Studies

Anastrozole can have a range of effects on the body, including bone density, the endometrium, drug metabolism, and side effects. These effects can vary between studies. 14 , 8 , 1 , 20 The effectiveness of combining anastrozole with tamoxifen has shown varied results in different studies. 16 When compared to letrozole, another aromatase inhibitor, letrozole has been shown to suppress estrogen production more effectively. 17

Consistency and Contradictions in Findings

There is both consistency and contradiction in the research findings regarding anastrozole's effects. 9 , 5 , 3 , 14 , 4 , 11 , 7 , 21 , 1 , 17 , 2 , 8 , 20 , 6 , 18 , 13 , 16 , 12 , 19 , 10 Specifically, the effect of anastrozole on bone density has shown inconsistent results. 14 , 21 Similarly, the combination of anastrozole with tamoxifen has shown contradictory results. 16

Considerations for Real-World Application

While anastrozole can be a valuable treatment option for postmenopausal women with early breast cancer, it is important to understand its potential risks and benefits. 9 , 5 , 3 , 4 , 11 , 7 , 21 , 20 The potential for decreased bone density and potential impact on the endometrium require careful monitoring. 14 , 8 Whether or not to use anastrozole should be discussed with a healthcare professional.

Limitations of Current Research

There is still a relatively limited amount of research on anastrozole. Many studies focus on specific populations, such as postmenopausal women, and the generalizability to other populations may be limited. 9 , 5 , 3 , 14 , 4 , 11 , 7 , 21 , 1 , 17 , 2 , 8 , 20 , 6 , 18 , 13 , 16 , 12 , 19 , 10 Long-term studies are also relatively limited, highlighting the need for further investigation.

Future Research Directions

Research is needed to evaluate the long-term effects of anastrozole, including its impact on bone density, the endometrium, drug metabolism, and side effects. 14 , 8 , 1 , 20 Further studies are needed to investigate the effectiveness of combining anastrozole with tamoxifen. 16 Research should also explore the effects of anastrozole in patients with varying ages and comorbidities. 18

Conclusion

Anastrozole shows potential as an effective treatment for early breast cancer in postmenopausal women. However, it is crucial to consider its potential risks, including decreased bone density and potential impact on the endometrium. 14 , 8 The decision to use anastrozole should be made in consultation with a healthcare professional. More research is necessary to fully understand the long-term effects of anastrozole and its efficacy in various patient groups. 9 , 5 , 3 , 4 , 11 , 7 , 21 , 1 , 17 , 2 , 8 , 20 , 6 , 18 , 13 , 16 , 12 , 19 , 10

Literature analysis of 21 papers
Positive Content
21
Neutral Content
0
Negative Content
0
Article Type
17
4
2
2
21
1.

The effect of anastrozole on the pharmacokinetics of tamoxifen in post-menopausal women with early breast cancer.

Author: DowsettM, TobiasJ S, HowellA, BlackmanG M, WelchH, KingN, PonzoneR, von EulerM, BaumM

Oestradiol Suppression

Anastrozole, an aromatase inhibitor, did not affect the pharmacokinetics of tamoxifen when given together to postmenopausal women with breast cancer. Anastrozole remained effective in suppressing oestradiol levels even in the presence of tamoxifen.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

A randomized, open, parallel-group trial to compare the endocrine effects of oral anastrozole (Arimidex) with intramuscular formestane in postmenopausal women with advanced breast cancer.

Author: VorobiofD A, KleebergU R, Perez-CarrionR, DodwellD J, RobertsonJ F, CalvoL, DowsettM, ClackG

Greater suppression of oestradiol

Anastrozole was found to provide more consistent and significantly more effective suppression of oestradiol compared with formestane.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Influence of letrozole and anastrozole on total body aromatization and plasma estrogen levels in postmenopausal breast cancer patients evaluated in a randomized, cross-over study.

Author: GeislerJürgen, HaynesBen, AnkerGun, DowsettMitch, LønningPer Eystein

Suppressed aromatase
Suppressed estrogen levels
None mentioned

Letrozole is a more potent suppressor of total-body aromatization and plasma estrogen levels than anastrozole in postmenopausal women with metastatic breast cancer. Letrozole 2.5 mg once daily resulted in a greater reduction in plasma levels of estrone, estradiol, and estrone sulfate than anastrozole 1 mg once daily.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

4.

Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial.

Author: BaumM, BudzarA U, CuzickJ, ForbesJ, HoughtonJ H, KlijnJ G M, SahmoudT,

Breast cancer treatment
Endometrial cancer
Thromboembolic disorders

Tamoxifen is an established treatment for postmenopausal women with hormone-sensitive breast cancer. This study aims to compare the safety and efficacy of tamoxifen with anastrozole alone and in combination.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Effect of neoadjuvant treatment with anastrozole on tumour histology in postmenopausal women with large operable breast cancer.

Author: AndersonT J, DixonJ M, StuartM, SahmoudT, MillerW R

Tumor shrinkage
Inconsistent effects

Anastrozole, a non-steroidal aromatase inhibitor, has been shown to be effective as neoadjuvant treatment for breast cancer. This study evaluated the histological changes in breast tumors after neoadjuvant anastrozole treatment. The study found that anastrozole treatment had marked effects on tumor histopathology, but these did not always correlate with clinical response.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

6.

Neoadjuvant treatment of postmenopausal breast cancer with anastrozole, tamoxifen, or both in combination: the Immediate Preoperative Anastrozole, Tamoxifen, or Combined with Tamoxifen (IMPACT) multicenter double-blind randomized trial.

Author: SmithIan E, DowsettMitch, EbbsStephen R, DixonJ Michael, SkeneAnthony, BlohmerJ-U, AshleySusan E, FrancisStephen, BoeddinghausIrene, WalshGeraldine,

Breast cancer treatment

This study aims to predict the outcome of an adjuvant therapy trial (ATAC) by comparing the effects of neoadjuvant tamoxifen, anastrozole, and a combination of both on postmenopausal women with breast cancer.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

7.

Comparative effects of anastrozole, tamoxifen alone and in combination on plasma lipids and bone-derived resorption during neoadjuvant therapy in the impact trial.

Author: BanerjeeS, SmithI E, FolkerdL, IqbalJ, BarkerP, DowsettM,

Bone preservation
Improved lipid profile
Increased bone resorption

Anastrozole did not have a detrimental effect on lipid profiles following 3 months of therapy. There was a significant increase in CTx with anastrozole in contrast to tamoxifen.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

8.

The ATAC ('Arimidex', Tamoxifen, Alone or in Combination) adjuvant breast cancer trial: first results of the endometrial sub-protocol following 2 years of treatment.

Author: DuffyS, JacksonT L, LansdownM, PhilipsK, WellsM, PollardS, ClackG, CoibionM, BiancoA R

Endometrial cancer risk reduction

Anastrozole, a third-generation aromatase inhibitor, may offer tolerability benefits in terms of effects on the endometrium compared to tamoxifen, which increases the risk of endometrial cancer.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

9.

Adjuvant endocrine therapy for postmenopausal women with early breast cancer.

Author: IngleJames N

Breast cancer treatment

This study examined the use of aromatase inhibitors in the treatment of postmenopausal women with hormone receptor-positive early breast cancer.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.

Language : English

10.

A prospective randomized trial comparing anastrozole and clomiphene citrate in an ovulation induction protocol using gonadotropins.

Author: SipeChristopher S, DavisWilliam A, MaifeldMichelle, Van VoorhisBradley J

Reduced hyperstimulation
Lower pregnancy rates

Anastrozole, when used in conjunction with gonadotropins, resulted in lower E(2) levels and fewer follicles than clomiphene citrate.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

11.

Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women.

Author: GibsonL J, DawsonC K, LawrenceD H, BlissJ M

Inhibit oestrogen synthesis
Treat breast cancer
Limited evidence on side effects

This review discusses hormonal treatments for advanced or metastatic breast cancer, including aromatase inhibitors (AIs). It highlights the development of AIs, including the third-generation AIs anastrozole, exemestane, and letrozole, and the limited randomized evidence on their response rates and side effects.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

12.

Molecular response to aromatase inhibitor treatment in primary breast cancer.

Author: MackayAlan, UrruticoecheaAnder, DixonJ Michael, DexterTim, FenwickKerry, AshworthAlan, DrurySuzanne, LarionovAlexey, YoungOliver, WhiteSharon, MillerWilliam R, EvansDean B, DowsettMitch

Effective estrogen suppression

Aromatase inhibitors, such as anastrozole and letrozole, effectively suppress estrogen synthesis in postmenopausal women. Their molecular effects on human breast carcinomas in vivo require further investigation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Effect of anastrozole and tamoxifen as adjuvant treatment for early-stage breast cancer: 100-month analysis of the ATAC trial.

Author: , ForbesJohn F, CuzickJack, BuzdarAman, HowellAnthony, TobiasJeffrey S, BaumMichael

breast cancer treatment
long-term outcomes

This study examines the long-term outcomes of anastrozole compared with tamoxifen after a median follow-up of 100 months in a trial of adjuvant treatment for breast cancer.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Effect of anastrozole on bone mineral density: 5-year results from the anastrozole, tamoxifen, alone or in combination trial 18233230.

Author: EastellRichard, AdamsJudith E, ColemanRobert E, HowellAnthony, HannonRosemary A, CuzickJack, MackeyJohn R, BeckmannMatthias W, ClackGlen

Breast cancer treatment
Bone mineral density
Fracture risk

Anastrozole, a medication used to treat breast cancer, may lower bone density in women with breast cancer. While anastrozole is effective in treating breast cancer, it may increase the risk of fractures in women with low bone density.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

15.

Aromatase inhibitors for treatment of advanced breast cancer in postmenopausal women.

Author: GibsonLorna, LawrenceDavid, DawsonClaire, BlissJudith

Tumor regression
Limited trial evidence

This review examines the use of aromatase inhibitors (AIs) in the treatment of advanced breast cancer. While AIs have shown similar tumor-regressing effects to other endocrine treatments, the evidence regarding their response rates and side effects is still limited.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.

Language : English

16.

Randomized biomarker trial of anastrozole or low-dose tamoxifen or their combination in subjects with breast intraepithelial neoplasia.

Author: BonanniBernardo, SerranoDavide, GandiniSara, Guerrieri-GonzagaAliana, JohanssonHarriet, MacisDebora, CazzanigaMassimiliano, LuiniAlberto, CassanoEnrico, OldaniSabina, LienErnst A, PelosiGiuseppe, DecensiAndrea

Breast cancer treatment
Estrogenic effects
Pharmacokinetic interactions

The combination of anastrozole and tamoxifen is inferior to anastrozole alone in terms of disease-free survival. This may be due to an adverse pharmacokinetic interaction or a predominant estrogenic effect of tamoxifen under estrogen deprivation.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

Anastrozole and letrozole: an investigation and comparison of quality of life and tolerability.

Author: DixonJ Michael, RenshawLorna, LangridgeCarolyn, YoungOliver E, McHughMary, WilliamsLinda, MurrayJuliette, MacaskillE Jane, McCaigFiona, DixonOliver M, FallowfieldLesley J

Well tolerated

Anastrozole and letrozole are well-tolerated aromatase inhibitors with similar effects on quality of life.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

18.

Influence of comorbidities and age on risk of death without recurrence: a retrospective analysis of the Arimidex, Tamoxifen Alone or in Combination trial.

Author: RingAlistair, SestakIvana, BaumMichael, HowellAnthony, BuzdarAman, DowsettMitch, ForbesJohn F, CuzickJack

Improved breast cancer survival
Increased risk of death from other causes

This study examined the effects of comorbidities and age on treatment outcomes in postmenopausal women with early-stage breast cancer. The study found that comorbidities and age can affect the treatment received, breast cancer-related mortality, and competing causes of mortality.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

19.

Effects of adjuvant exemestane versus anastrozole on bone mineral density for women with early breast cancer (MA.27B): a companion analysis of a randomised controlled trial.

Author: GossPaul E, HershmanDawn L, CheungAngela M, IngleJames N, KhoslaSundeep, StearnsVered, ChalchalHaji, RowlandKendrith, MussHyman B, LindenHannah M, ScherJudite, PritchardKathleen I, ElliottCatherine R, Badovinac-CrnjevicTanja, St LouisJessica, ChapmanJudith-Anne W, ShepherdLois E

Breast cancer treatment
Bone damage

Exemestane, an aromatase inhibitor used for breast cancer treatment, may have a less detrimental effect on bone mineral density than anastrozole, another aromatase inhibitor. This suggests that exemestane, with its mild androgenic properties, may be a better option for bone health in breast cancer patients.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

21.

Assessment and management of bone health in women with early breast cancer receiving endocrine treatment in the DATA study.

Author: van HellemondIrene E G, SmorenburgCarolien H, PeerPetronella G M, SwinkelsAstrid C P, SeynaeveCaroline M, van der SangenMaurice J C, KroepJudith R, de GraafHiltje, HonkoopAafke H, ErdkampFrans L G, van den BerkmortelFranchette W P J, de BoerMaaike, de RoosWilfred K, LinnSabine C, ImholzAlexander L T, Tjan-HeijnenVivianne C G,

Breast cancer treatment
Bone density loss

Extended anastrozole therapy (6 years) was not associated with a higher incidence of osteoporosis compared to shorter therapy (3 years). Anastrozole use was associated with a modest decrease in bone mineral density, partially reversible after anastrozole cessation.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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