This trial is active, not recruiting.

Condition breast cancer
Treatments anastrozole, fulvestrant
Phase phase 2
Start date August 2007
End date September 2016
Trial size 116 participants
Trial identifier NCT00629616, 2006-006409-10, CARMINA-02/0609, CARMINA02, NIMFEA


RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole or fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes or by blocking the use of estrogen by the tumor cells. Giving hormone therapy before surgery may be an effective treatment for breast cancer. It is not yet known whether anastrozole is more effective than fulvestrant when given before surgery in treating women with breast cancer.

PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal women with stage II or stage III breast cancer that can be removed by surgery.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
1 mg/day for either 4 months or 6 months depending on the clinical evaluation
500mg at day 1, day 15 and day 29 500mg every 28 days for either 4 months or 6 months depending on the clinical evaluation

Primary Outcomes

Clinical tumor response as assessed by RECIST criteria
time frame: 6 months

Secondary Outcomes

Breast surgery conservation rate
time frame: Post surgery
Histological tumor response as assessed by the Sataloff scale
time frame: Post surgery
Tumor response as assessed by mammography, ultrasonography (RECIST criteria), and MRI
time frame: at baseline, after the first month of treatment, and then before surgery
Biological prognosis and predictive response factors
time frame: 3 years
Relapse-free survival rate
time frame: 3 years
Event-free survival rate
time frame: 3 years
Overall survival rate
time frame: 3 years
Toxicity as assessed by NCI CTCAE v3.0
time frame: During neoadjuvant treatment

Eligibility Criteria

Female participants of any age.

DISEASE CHARACTERISTICS: - Histologically confirmed infiltrating breast adenocarcinoma - Large, operable tumor - Stage T2 (≥ 3 cm) or T3-T4 (excluding inflammatory disease), N0-N3, M0 disease - No bilateral inflammatory breast tumors (T4d [PEV-2 or PEV-3]) - Elston-Ellis grade I or II and mitotic index 1 or 2 (if < 65 years of age) - At least 1 embedded and 1 frozen biopsy sample available - No multifocal or multicentric tumors for which breast conservation cannot be envisaged - No ErbB2-overexpressing tumors (HER2 3+ by IHC OR HER2 2+ by IHC and FISH positive) - Hormone receptor status: - Estrogen receptor and/or progesterone receptor positive tumor (> 10%) as assessed by IHC PATIENT CHARACTERISTICS: - Female - Postmenopausal - ECOG performance status 0-2 - ANC ≥ 2,000/mm³ - Platelet count ≥ 100,000/mm³ - Hemoglobin ≥ 10 g/dL - Creatinine ≤ 1.5 times upper limit of normal (ULN) - Total bilirubin ≤ 1.25 times ULN - AST and ALT ≤ 1.5 times ULN - Alkaline phosphatase ≤ 2.5 times ULN - No other cancer within the past 10 years, except basal cell skin cancer or previously treated carcinoma in situ of the cervix - No uncontrolled cardiac pathology, including any of the following: - Angina pectoris - Congestive cardiac insufficiency - Myocardial infarction within the past 3 months - No known history of hemorrhagic diathesis - No known allergy to the study drugs or their excipients - No congenital galactosemia, glucose malabsorption syndrome, or lactase deficiency - No chronic somatic or psychiatric illness with pejorative prognosis - No geographical, social, or psychiatric condition that would preclude study compliance and follow-up schedule - No individual deprived of liberty or placed under the authority of a tutor PRIOR CONCURRENT THERAPY: - No prior chemotherapy, hormonal therapy, or any targeted treatment for the breast tumor - At least 2 weeks since prior hormone replacement therapy for menopause - No concurrent long-term anticoagulation treatment - No concurrent participation on another therapeutic trial involving an experimental molecule

Additional Information

Official title A Randomized Multicenter Phase II Study Identifying Hormone Sensitivity Profiles and Evaluating the Efficacy of Anastrozole and Fulvestrant in the Neo-adjuvant Treatment of Operable Breast Cancer in Postmenopausal Women.
Principal investigator Florence Lerebours, MD
Description OBJECTIVES: Primary - To compare the clinical response rates (complete and partial responses) at 6 months in postmenopausal women with operable stage II or III breast cancer treated with neoadjuvant anastrozole vs fulvestrant. Secondary - To compare the breast surgery conservation rate in patients treated with these drugs. - To correlate imaging findings by mammography, ultrasonography, and MRI with histological and clinical response in these patients and with sensitivity profile to these drugs. - To compare histological response in patients treated with these drugs. - To define criteria appropriate for neoadjuvant hormonal therapy. - To correlate baseline molecular characteristics and modifications during treatment with response in these patients. - To compare the tolerability of these drugs in these patients. - To compare the serum proteomic profile of patients treated with these drugs. - To correlate 3-year event-free and overall survival rates with clinical and histological response in these patients. OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral anastrozole once daily for 4-6 months in the absence of clinical progression. - Arm II: Patients receive fulvestrant intramuscularly on days 1, 15, and 29 in the first month and then every 28 days in each subsequent month. Treatment continues for 4-6 months in the absence of clinical progression. Patients in both arms then undergo surgery and radiotherapy according to institutional guidelines. Patients then receive adjuvant hormonal therapy for at least 5 years. After completion of study therapy, patients are followed periodically for up to 3 years.
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by UNICANCER.