DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



S0307 Zoledronate, Clodronate, or Ibandronate in Treating Women Who Have Undergone Surgery for Stage I, Stage II, or Stage III Breast Cancer

Information source: Southwest Oncology Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: clodronate disodium (Drug); ibandronate sodium (Drug); zoledronic acid (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Southwest Oncology Group

Official(s) and/or principal investigator(s):
Julie R. Gralow, MD, Study Chair, Affiliation: Seattle Cancer Care Alliance
Robert B. Livingston, MD, Study Chair, Affiliation: University of Arizona
James N. Ingle, MD, Study Chair, Affiliation: Mayo Clinic
Carla I. Falkson, MD, Study Chair, Affiliation: University of Alabama at Birmingham
Alexander H Paterson, MD, FRCP, Study Chair, Affiliation: Tom Baker Cancer Centre - Calgary
Elizabeth C. Dees, MD, Study Chair, Affiliation: UNC Lineberger Comprehensive Cancer Center
Mark J. Clemons, MD, Study Chair, Affiliation: Odette Cancer Centre at Sunnybrook

Summary

RATIONALE: Zoledronate, clodronate, or ibandronate may delay or prevent bone metastases in patients with nonmetastatic breast cancer. It is not yet known whether zoledronate is more effective than clodronate or ibandronate in treating breast cancer. PURPOSE: This randomized phase III trial is studying zoledronate to see how well it works compared to clodronate or ibandronate in treating women who have undergone surgery for stage I, stage II, or stage III breast cancer.

Clinical Details

Official title: Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Histologic confirmation of disease recurrence

Sites of first disease recurrence

Disease-free survival

Overall survival

Zubrod performance status

Secondary outcome: Correlation of inherited germ-line single nucleotide polymorphisms (SNP, rs2297480) in farnesyl diphosphate synthase (FDPS) with adverse event of acute phase reactions

Detailed description: OBJECTIVES:

- Compare disease-free survival and overall survival of women with resected primary stage

I-III adenocarcinoma of the breast treated with adjuvant zoledronate vs clodronate vs ibandronate.

- Compare the distributions of sites of first disease recurrence in patients treated with

these drugs.

- Compare adverse events in patients treated with these drugs.

- Correlate parathyroid hormone related protein status and N-telopeptide levels at

baseline with disease-free survival and sites of first recurrence in patients treated with these drugs.

- Investigate whether there is an association between inherited germ-line single

nucleotide polymorphisms (SNP, rs2297480) in farnesyl diphosphate synthase (FDPS) and the adverse event of acute phase reactions in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

- Arm I: Patients receive zoledronate IV over 15 minutes once a month for 6 months and

then once every 3 months for 2. 5 years.

- Arm II: Patients receive oral clodronate once daily for 35 months.

- Arm III: Patients receive oral ibandronate once daily for 35 months. Treatment in all

arms continues in the absence of disease recurrence or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months until disease recurrence and then annually for up to 10 years. PROJECTED ACCRUAL: A total of 5,400 will be accrued for this study.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

DISEASE CHARACTERISTICS:

- Histologically confirmed primary adenocarcinoma of the breast

- Stage I-III disease

- No evidence of metastatic disease

- Must have undergone lumpectomy or total mastectomy for primary disease within the

past 12 weeks, or have completed chemotherapy within the past 8 weeks

- Axillary evaluation per institutional standards

- Currently receiving or planning to receive standard adjuvant systemic therapy

comprising chemotherapy, hormonal therapy, or combined chemotherapy/hormonal therapy for breast cancer

- Patients who are at low risk for disease recurrence and for whom adjuvant

systemic therapy will not be prescribed are not eligible

- Patients who receive biologic agents only or local radiotherapy only (without

chemotherapy and/or hormone therapy) are not eligible

- Additional therapies are allowed including radiotherapy and biologic agents

(e. g., trastuzumab [Herceptin^®], bevacizumab, or hematopoietic growth factors)

- Neoadjuvant therapy or hormonal therapy alone is allowed provided study entry

occurs ≥ 12 weeks after completion of surgery

- Patients with skeletal pain are eligible provided bone scan and/or roentgenological

exam are negative for metastatic disease

- Suspicious findings must be confirmed as benign by x-ray, MRI, or biopsy

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS: Age

- 18 and over

Sex

- Female

Menopausal status

- Not specified

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Creatinine ≤ 2 times upper limit of normal

- Creatinine clearance ≥ 30 mL/min

- No renal failure

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No history of esophageal stricture or motility disorders

- Gastroesophageal reflux disorder allowed

- No other malignancy within the past 5 years except adequately treated basal cell or

squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy

- Prior or concurrent hematopoietic growth factors allowed

- HER-2-targeted therapies allowed

- Antiangiogenics allowed

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- See Disease Characteristics

Radiotherapy

- Concurrent radiotherapy to the breast, chest wall, or lymph node group allowed at the

discretion of the treating physician Surgery

- See Disease Characteristics

Other

- Prior neoadjuvant therapy allowed

- Prior bisphosphonates for bone density allowed

- No other concurrent bisphosphonates as adjuvant therapy or for treatment of

osteoporosis

- No concurrent enrollment in clinical trials with bone density as an endpoint

- Concurrent enrollment on any other locoregional or systemic therapy breast

cancer study (including cooperative group studies) allowed

Locations and Contacts

Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Featured trial article

Starting date: July 2005
Last updated: May 8, 2015

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017