Anastrozole or Fulvestrant in Treating Postmenopausal Patients With Breast Cancer
Recruitment status was Recruiting
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Purpose
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes. Fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. It is not yet known whether anastrozole is more effective than fulvestrant before surgery and radiation therapy in treating patients with breast cancer.
PURPOSE: This randomized phase II trial is studying anastrozole to see how well it works compared with fulvestrant in treating postmenopausal patients with breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: anastrozole Drug: fulvestrant |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Response to Neoadjuvant Treatment With Anti-aromatase Anastrozole and Anti-estrogen Fulvestrant: a Randomized Phase II Study in Postmenopausal Patients With Hormone-sensitive Nonmetastatic Breast Cancer and an Exploratory Study of Molecular Signatures of Response |
- Tumor response at 6 months of treatment according to RECIST criteria [ Designated as safety issue: No ]
| Estimated Enrollment: | 114 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I
Patients receive oral anastrozole once daily for 6 months.
|
Drug: anastrozole
Given orally
|
|
Experimental: Arm II
Patients receive fulvestrant intramuscularly on days 1, 14, and 28 and then once a month at 2-6 months.
|
Drug: fulvestrant
Given intramuscularly
|
Detailed Description:
OBJECTIVES:
Primary
- Evaluate clinical tumor response at 6 months in patients with hormone-sensitive nonmetastatic breast cancer treated with neoadjuvant anastrozole vs fulvestrant.
Secondary
- Evaluate tumor regression by mammography and ultrasound in these patients.
- Evaluate the rate of breast conservation at 6 months of treatment in these patients.
- Evaluate the tolerability of these regimens.
- Estimate the progression-free survival at 5 years of these patients.
- Identify molecular signatures predictive of response in these patients.
- Identify genes implicated in response in these patients.
- Identify changes in mRNA splicing of genes involved in breast tumorigenesis.
OUTLINE: This is a multicenter study.
All patients undergo biopsy at baseline. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral anastrozole once daily for 6 months.
- Arm II: Patients receive fulvestrant intramuscularly on days 1, 14, and 28 and then once a month at 2-6 months.
Within 8 days after completion of hormone therapy, all patients undergo surgical resection of the residual lesion followed by radiotherapy. Patients then receive oral anastrozole once daily for 5 years.
Tissue samples from biopsy and surgery are analyzed to assess molecular signatures and sensitivity to treatment, and to compare gene expression variation with response.
Eligibility| Ages Eligible for Study: | up to 84 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer, meeting 1 of the following criteria:
- SBR grade I-II disease (patients < 65 years of age)
- SBR grade I-III disease (patients > 65 years of age)
- T2 (2-5 cm), T3, or T4B, and N0-1 disease
- No metastatic disease
- Breast lesion not amenable to breast-conserving resection
- No inflammatory breast cancer
- No prior breast cancer
Hormone receptor status:
- Estrogen receptor- and/or progesterone receptor-positive
PATIENT CHARACTERISTICS:
- Postmenopausal
- No other cancer within the past 5 years except for adequately treated skin carcinoma or carcinoma in situ of the cervix
- No contraindication to anti-hormonal treatment
- No psychological, familial, social, or geographical reasons that would preclude follow up
PRIOR CONCURRENT THERAPY:
- At least 8 days since prior hormone replacement therapy
- No concurrent anti-vitamin K treatment
Contacts and Locations| France | |
| Institut Bergonie | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Louis Mauriac, MD 33-56-333-258 mauriac@bergonie.org | |
| Principal Investigator: | Louis Mauriac, MD | Institut Bergonié |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00871858 History of Changes |
| Other Study ID Numbers: | CDR0000633329, IB-HORGEN, IB-IB2007-26, INCA-RECF0514, EUDRACT-2007-004216-31, ZENECA-IB-HORGEN |
| Study First Received: | March 27, 2009 |
| Last Updated: | January 7, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage II breast cancer stage IIIA breast cancer stage IIIB 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 Estrogens Estradiol Fulvestrant Anastrozole Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Antineoplastic Agents, Hormonal Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013