Clinical trial · Interventional
Study of Anastrozole, Letrozole, or Exemestane With or Without Tamoxifen in Treating Postmenopausal Women With Hormone-Responsive Breast Cancer That Has Been Completely Removed By Surgery
A Phase III Study Comparing Anastrozole, Letrozole and Exemestane, Upfront (for 5 Years) or Sequentially (for 3 Years After 2 Years of Tamoxifen), as Adjuvant Treatment of Postmenopausal Patients With Endocrine-responsive Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking use of estrogen by the tumor cells. Anastrozole, letrozole, and exemestane may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether giving tamoxifen followed by anastrozole, letrozole, or exemestane is more effective than giving anastrozole, letrozole, or exemestane alone in treating breast cancer. PURPOSE: This randomized phase III trial is studying giving tamoxifen followed by either anastrozole, letrozole, or exemestane to see how well it works compared to anastrozole, letrozole, or exemestane alone in treating postmenopausal women with hormone-responsive invasive breast cancer that has been completely removed by surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anastrozole | Drug | Anastrozole | ALIAS |
| exemestane | Drug | Exemestane | ALIAS |
| letrozole | Drug | Letrozole | ALIAS |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- A - anastrozole
- description
- Up-front adjuvant anastrozole for 5 years
- interventionNames
- Drug: anastrozole
- type
- EXPERIMENTAL
- label
- B - exemestane
- description
- Up-front adjuvant exemestane for 5 years
- interventionNames
- Drug: exemestane
- type
- EXPERIMENTAL
- label
- C - letrozole
- description
- Up-front adjuvant letrozole for 5 years
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive breast cancer completely removed by surgery
* Any T, any N
* No recurrent or metastatic disease
* Estrogen or progesterone receptor-positive disease in primary tumor, as defined by 1 of the following:
* At least 10% of tumor cells positive by immunohistochemistry
* At least 10 fmol/mg cytosol protein by ligand binding assay
* Patients with HER-2/neu positive tumors are eligible provided they receive trastuzumab (Herceptin®) according to the registered schedule
PATIENT CHARACTERISTICS:
* Female
* Postmenopausal, defined by ≥ 1 of the following:
* Age ≥ 60 years
* Age 45-59 and satisfying 1 or more of the following criteria:
* Amenorrhea for ≥ 12 months AND intact uterus
* Amenorrhea (secondary to hysterectomy, hormone replacement therapy (HRT), or chemotherapy) for \< 12 months AND follicle-stimulating hormone within the postmenopausal range
* Underwent prior bilateral oophorectomy at any age \>18 years
* No concurrent illness that contraindicates adjuvant endocrine treatment
* No other invasive breast cancer or invasive malignancy within the past 10 years, except adequately cone-biopsied squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
* No concurrent disease that would place the patient at unusual risk
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* Adjuvant or neoadjuvant chemotherapy must be completed prior to study entry
* At least 1 month since prior and no concurrent HRT
* More than 30 days since prior systemic investigational drugs
* No prior tamoxifen as part of any breast cancer prevention study
* Prior or concurrent locoregional radiotherapy allowed
* No other concurrent experimental drugs
* No concurrent bisphosphonates, unless indicated as treatment for osteoporosisReferences
Publications (1)
- DERIVEDDe Placido S, Gallo C, De Laurentiis M, Bisagni G, Arpino G, Sarobba MG, Riccardi F, Russo A, Del Mastro L, Cogoni AA, Cognetti F, Gori S, Foglietta J, Frassoldati A, Amoroso D, Laudadio L, Moscetti L, Montemurro F, Verusio C, Bernardo A, Lorusso V, Gravina A, Moretti G, Lauria R, Lai A, Mocerino C, Rizzo S, Nuzzo F, Carlini P, Perrone F; GIM Investigators. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):474-485. doi: 10.1016/S1470-2045(18)30116-5. Epub 2018 Feb 23. PMID 29482983