Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer

• Status: Terminated
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Female

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 cause the growth of breast cancer cells. Hormone therapy using exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen the body makes. Drugs used in chemotherapy, such as capecitabine, methotrexate, vinorelbine ditartrate, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: National Cancer Institute (NCI)
• Treatments: Capecitabine; Exemestane; Hormones; Methotrexate; Paclitaxel; Triptorelin Pamoate; Vinorelbine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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