Clodronate With or Without Chemotherapy and/or Hormonal Therapy in Treating Women With Stage I or Stage II Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00009945|
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : November 20, 2017
Last Update Posted : December 13, 2017
RATIONALE: Clodronate may be effective in preventing the spread of cancer to the bones and other parts of the body. It is not yet known whether clodronate is more effective alone or combined with chemotherapy and /or hormonal therapy in preventing metastatic breast cancer.
PURPOSE: Randomized phase III trial to determine the effectiveness of clodronate with or without chemotherapy and /or hormonal therapy in preventing metastases in women who have stage I or stage II breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: clodronate Drug: placebo||Phase 3|
- Determine whether clodronate administered alone or in addition to adjuvant chemotherapy and/or hormonal therapy improves disease-free survival in women with early stage breast cancer.
- Determine whether clodronate reduces the incidence of skeletal metastases and non-skeletal metastases in these patients.
- Determine whether clodronate improves overall and relapse-free survival in these patients.
- Determine whether clodronate reduces the incidence of skeletal morbidity (e.g., skeletal fractures, hypercalcemia, skeletal pain, need for radiotherapy, spinal cord compression) in these patients.
- Investigate the relevance of serum markers of bone turnover as a prognostic factor for the development of bone metastasis in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified by age (under 50 vs 50 and over), number of positive lymph nodes (0 vs 1-3 vs 4 or more), and hormone receptor status (estrogen receptor [ER] and progesterone receptor [PR] negative vs ER and/or PR positive). Patients are randomized to one of two treatment arms.
Patients in both arms commence treatment within 2 weeks of randomization and continue treatment for 3 years in the absence of bone metastasis or unacceptable toxicity. Study medication must be continued in the case of documented visceral or soft tissue metastasis or other event without skeletal metastasis.
Patients in both arms may also receive adjuvant chemotherapy and/or tamoxifen at the discretion of the protocol investigator. Patients receiving hormonal therapy begin hormonal therapy within 3-12 weeks after the last dose of chemotherapy and continue for a minimum of 5 years.
Patients who have undergone a prior lumpectomy receive adjuvant whole breast radiotherapy. Patients who have undergone a prior mastectomy may receive radiotherapy at the investigator's discretion.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 3,323 patients will be accrued for this study within 3.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3323 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Clinical Trial Comparing Adjuvant Clodronate Therapy vs Placebo in Early-Stage Breast Cancer Patients Receiving Systemic Chemotherapy and/or Hormonal Therapy or No Therapy|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||December 2012|
Experimental: Arm 1: Clodronate
Patient receives 2 tablets once daily for 3 years.
1600 mg PO daily
Placebo Comparator: Arm 2: Placebo
Patient receives 2 tablets once daily for 3 years.
2 pills PO daily
- Disease Free Survival. [ Time Frame: 8 years ]Time to first event where an event is any recurrences, 2nd primary or death to determine the percentage of patients disease free at 8 years
- Skeletal Metastasis Free Survival [ Time Frame: 8 years ]Time from randomization to first diagnosis of skeletal metastasis to determine the percentage of patient free of skeletal metastasis at 8 years
- Overall Survival [ Time Frame: 8 years ]Time from randomization to any death to determine the percentage of patients alive at 8 years
- Relapse Free Survival [ Time Frame: 8 years ]Time from randomization to any local, regional, or distant recurrence of breast cancer to determine the percentage of patients relapse free at 8 years
- Incidence of Non-skeletal Metastasis [ Time Frame: 8 years ]Time from randomization to incidence of non-skeletal metastasis to determine the percentage of patients free from non-skeletal metastasis at 8 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00009945
|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|