Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

RATIONALE: Zoledronate may delay or prevent the formation of bone metastases. It is not yet known whether chemotherapy and/or hormone therapy are more effective with or without zoledronate in preventing cancer recurrence and bone metastases in women with breast cancer.

PURPOSE: This randomized phase III trial is studying giving chemotherapy and/or hormone therapy together with zoledronate to see how well they work compared to chemotherapy and/or hormone therapy alone in preventing cancer recurrence and bone metastases in women with stage II or stage III breast cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Sheffield
• Treatments: Diphosphonates; Zoledronic Acid

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of primary breast cancer, meeting 1 of the following staging criteria:

• Stage II

• Stage III

• T stage ≥ T1

• Receiving OR scheduled to receive chemotherapy and/or endocrine therapy

• For patients receiving neoadjuvant therapy

• Tumor > 5 cm (T3), features of locally advanced disease (T4), OR biopsy-proven lymph node involvement (N1)

• Scheduled to proceed to definitive surgery and/or radical radiotherapy with curative intent within 6 months of starting neoadjuvant therapy

• No more than 30 days between initiation of neoadjuvant therapy and start of study drug

• For patients receiving adjuvant therapy

• Must have undergone complete primary tumor resection and treatment of axillary lymph nodes*

• Must have lymph node involvement

• No prior neoadjuvant therapy**

• No more than 60 days since prior definitive surgery NOTE: *Patients whose treatment plan includes further primary tumor resection and/or treatment of the axillary lymph nodes (e.g., clearance or radiotherapy) with curative intent after completion of chemotherapy are eligible provided the treatment is completed within 9 months of study entry

NOTE: **Preoperative endocrine therapy with a duration of < 30 days is not considered prior neoadjuvant therapy

• No evidence of recurrent or metastatic disease

• No history of breast cancer, except ductal carcinoma in situ or lobular carcinoma in situ

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Female

Menopausal status

• Premenopausal or postmenopausal

Performance status

• Karnofsky 80-100% OR

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Creatinine ≤ 1.5 times upper limit of normal

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No active dental problems, including dental abscess or infection of the jaw bone (e.g., maxilla or mandible)

• No prior or current diagnosis of osteonecrosis of the jaw

• No other malignancy within the past 5 years (including prior contralateral breast cancer) except nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix

• No history of disease with influence on bone metabolism, including any of the following:

• Paget's disease of the bone

• Primary hyperparathyroidism

• Osteoporosis requiring treatment or likely to require treatment within the next 6 months

• No other severe physical or psychological disease that would preclude study compliance

• No known hypersensitivity to bisphosphonates

PRIOR CONCURRENT THERAPY:

Chemotherapy

• See Disease Characteristics

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

• More than 4 weeks since prior and no concurrent dental or jaw surgery (e.g., extractions or implants)

• Dental fillings, teeth scaling and polishing, or minor gingival surgery within the past 4 weeks are allowed

Other

• More than 1 year since prior bisphosphonates

• More than 30 days since prior investigational drugs

• No concurrent investigational drugs (i.e., not locally approved for any indication)