Status:
TERMINATED
Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Estrogen Receptor-positive Breast Cancer
HER2-negative Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer. Estrogen can...
Detailed Description
PRIMARY OBJECTIVES: I. To assess the pathologic response rate in patients with operable breast cancer treated with a two part, neoadjuvant regimen consisting of complete hormonal blockade (CHB) for 2...
Eligibility Criteria
Inclusion
- Have histologically confirmed, operable ER or PR +, HER2/neu negative, radiographically measurable breast cancer \> 1cm (Operable lesions are T1c - T3 and N0 - N2a; histologic confirmation should be by core needle biopsy only)
- Be chemotherapy naive
- Have an ECOG performance status of =\< 2
- Be assessed for menopausal status (For study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or age 60 or older with a prior hysterectomy without oophorectomy, or Age less than 60 with a prior hysterectomy without oophorectomy \[or in whom the status of the ovaries is unknown\], with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab)
- All premenopausal patients must have a baseline FSH and LH
- ANC \>= 1,500
- Platelet count \>= 100,000
- Serum creatinine =\< 1.5 x IULN
- Estimated creatinine clearance \> 50 ml/min
- Have staging studies and tumor assessment prior to registration
- Bone density exam must be done within the first 3 months of complete hormonal blockade
- Have a negative pregnancy test within seven days prior to registration if of childbearing potential
- Be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study specific screening procedures
Exclusion
- Primary tumor =\< 1 cm, not measurable; inflammatory disease
- Pregnant or lactating; women of childbearing potential with either a positive or no pregnancy test at baseline are excluded (Women of childbearing potential who are not using a reliable and appropriate contraceptive method are excluded; patients must agree to continue contraception for 30 days from the last study drug administration)
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil
- Previous enrollment in an investigational drug study within the last 4 weeks
- Evidence of distant metastatic disease
- Prior chemotherapy or hormonal therapy for breast cancer
- Prior malignancy other than adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, other stage I or II cancer from which the patient has been disease free for at least 5 years
- History of uncontrolled seizures, central nervous system disorders, or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance with oral drug intake
- Any other life-threatening illness (e.g. serious, uncontrolled concurrent infection or clinically significant cardiac disease - congestive heart failure, symptomatic coronary artery disease, cardiac arrhythmia not well controlled with medication or myocardial infarction
- Major surgery within four weeks of the start of study treatment without complete recovery
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
- Known, existing uncontrolled coagulopathy
- Unwillingness to give informed consent
- Unwillingness to participate or inability to comply with the protocol for the duration of the study
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00194792
Start Date
August 1 2005
End Date
July 1 2011
Last Update
July 11 2017
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109