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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: anastrozole Drug: exemestane Drug: letrozole Drug: tamoxifen citrate Procedure: adjuvant therapy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
- Disease-free survival [ Designated as safety issue: No ]
- Overall Survival [ Designated as safety issue: No ]
- Distant metastasis-free survival [ Designated as safety issue: No ]
- Cumulative incidence of contralateral breast cancer as first event [ Designated as safety issue: No ]
- Breast cancer-free survival [ Designated as safety issue: No ]
- Cumulative incidence and type of second non-breast invasive cancer [ Designated as safety issue: No ]
- Effects on lipid profile [ Designated as safety issue: No ]
- Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 10000 |
| Study Start Date: | March 2007 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- To compare sequential tamoxifen for 2 years followed by anastrozole, letrozole, or exemestane for 3 years vs anastrozole, letrozole, or exemestane for 5 years in terms of disease-free survival in postmenopausal women with nonrecurrent, nonmetastatic invasive endocrine-responsive breast cancer.
- To compare disease-free survival in patients treated with anastrozole vs letrozole vs exemestane.
OUTLINE: This is a multicenter study. Patients are stratified according to hormone receptor status (estrogen receptor [ER]-positive and progesterone [PgR] receptor-positive disease vs ER-positive and PgR-negative disease vs ER-negative and PgR-positive disease vs ER- or PgR-positive disease or ER or PgR status unknown), HER-2/neu status (positive [3+ by IHC or positive by fluorescence in situ hybridization ( FISH)] vs negative vs unknown), prior chemotherapy (none vs adjuvant vs neoadjuvant vs both adjuvant and neoadjuvant), and nodal status (pN0 vs pN1 vs pN2 vs pN3). Patients are randomized to 1 of 6 treatment arms.
- Arm I: Patients receive oral anastrozole once daily for 5 years.
- Arm II: Patients receive oral exemestane once daily for 5 years.
- Arm III: Patients receive oral letrozole once daily for 5 years.
- Arm IV: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral anastrazole once daily for 3 years.
- Arm V: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral exemestane once daily for 3 years.
- Arm VI: Patients receive oral tamoxifen citrate once daily for 2 years followed by oral letrozole once daily for 3 years.
Treatment in all arms continues in the absence of disease recurrence or unacceptable toxicity.
After completion of study therapy, patients are followed periodically.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 osteoporosis
Contacts and Locations| Italy | |
| Federico II University Medical School | Recruiting |
| Naples, Italy, 80131 | |
| Contact: Sabino De Placido, MD 39-081-746-3660 deplacid@unina.it | |
| Istituto Nazionale per lo Studio e la Cura dei Tumori | Recruiting |
| Naples, Italy, 80131 | |
| Contact: Francesco Perrone, MD 39-81-590-3571 | |
| Seconda Universita di Napoli | Recruiting |
| Naples, Italy, 80138 | |
| Contact: Ciro Gallo 39-81-566-6021 | |
| Arcispedale S. Maria Nuova | Recruiting |
| Reggio Emilia, Italy, 42100 | |
| Contact: Corrado Boni, MD 39-522-296-546 boni.corrado@asmn.re.it | |
| Istituti Fisioterapici Ospitalieri - Roma | Recruiting |
| Rome, Italy, 00128 | |
| Contact: Francesco Cognetti, MD 39-06-5266-6919 cognetti@ifo.it | |
| Study Chair: | Sabino De Placido, MD | Federico II University |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00541086 History of Changes |
| Other Study ID Numbers: | CDR0000570041, GIM-3-FATA, EUDRACT-2006-004018-42, EU-20764 |
| Study First Received: | October 5, 2007 |
| Last Updated: | November 10, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage IA breast cancer stage IB breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer estrogen receptor-positive breast cancer progesterone receptor-positive breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic Tamoxifen Anastrozole Exemestane Letrozole Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Estrogen Antagonists Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013