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MGF Igf-1-ec

IGF-1Ec, IGF-1Eb, Mechano-Growth Factor

Quick Stats
Studies 62
Trials 100
Terminated PHASE2 INTERVENTIONAL NCT00925652

Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

If residual breast cancer is found in the breast or lymph node tissue removed after preoperative chemotherapy, one may be at increased risk of breast cancer recurrence in the future. The purpose of this research study is to determine if having additional treatment after preoperative chemotherapy and surgery with bevacizumab and metronomic chemotherapy would make a difference in reducing the participants chance of breast cancer recurrence compared to the standard of care, which is observation alone. This study will also evaluate the potential additional benefits from participating in an exercise and dietary intervention compared to the dietary intervention alone. Because no one knows which which post-neoadjuvant strategy is best, participants will be "randomized" to one of the study groups: 1. Diet Intervention arm, 2. Diet and Exercise Intervention Arm, 3. Bevacizumab, cyclophosphamide, methotrexate and diet intervention, 4. Bevacizumab, cyclophosphamide, methotrexate, diet and exercise intervention arm.

Detailed Description

Bevacizumab is an antibody that is made in the laboratory. Bevacizumab works differently from the way chemotherapy drugs work. Bevacizumab works to slow or stop the growth of cells in cancer tumors by decreasing the blood supply to tumors. Bevacizumab has been approved by the U.S Food and Drug Administration to treat advanced colorectal, lung and kidney cancers. Metronomic chemotherapy also attacks tumor blood supply. Standard chemotherapy drugs are used, cyclophosphamide and methotrexate (CM), but in very small daily doses by mouth, well below the threshold where they can cause people to feel sick. Previous research studies have shown that women with breast cancer who take metronomic CM and bevacizumab feel very well, and the combination therapy is active in reducing their cancer. Participants in this study will also be provided with diet or diet and exercise counseling over the telephone. Studies have shown that many women who are treated for breast cancer will gain weight during and after their treatment, and may also experience fatigue and weakness. Many studies have shown that making changes in diet and increasing exercise can help prevent weight gain and also may increase energy and decrease other side effects of chemotherapy and other breast cancer treatments.

Interventions

Name: Bevacizumab
Type: DRUG
Description:
Name: Cyclophosphamide
Type: DRUG
Description:
Name: Methotrexate
Type: DRUG
Description:
Name: Lifestyle: Diet
Type: BEHAVIORAL
Description:
Name: Lifestyle: Diet+Exercise
Type: BEHAVIORAL
Description:

Primary Outcomes

Measure: Median 3-year Recurrence-free Survival (RFS)
TimeFrame: Disease assessments occurred every 12 weeks on treatment and every 6 months in long-term follow-up up to 7.5 years.
Description: RFS events is defined as the duration of time from randomization to time of an RFS event, marked as positive if any of listed event shows: local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive), any other second cancer (excluding non-melanomatous skin cancer or cervical cancer in situ), or death from any cause. The diagnosis of local or distant recurrence should be pathologically confirmed however if biopsy if not possible, radiology confirmation acceptable.

Trial Information

NCT ID

NCT00925652

Status

Terminated

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Dana-Farber Cancer Institute

Last Updated

December 15, 2025