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Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a Prospective Randomized Trial Evaluating Chemotherapy after Local Therapy for Isolated Locoregional Recurrences of Breast Cancer

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

The utility of chemotherapy for women who experience a locoregional recurrence after primary treatment of early breast cancer remains an open question. An international collaborative trial is being conducted by the Breast International Group (BIG), the International Breast Cancer Study Group (IBCSG), and the National Surgical Adjuvant Breast and Bowel Project (NSABP) to determine the effectiveness of cytotoxic therapy for these patients, either alone or in addition to selective use of hormonal therapy and trastuzumab.

Methods

The trial population includes women who have had a previous diagnosis of invasive breast cancer treated by mastectomy or breast-conserving surgery, but subsequently develop an isolated local and/or regional ipsilateral invasive recurrence. Excision of all macroscopic tumor without evidence of systemic disease is required for study entry. Patients are randomized to receive chemotherapy or no chemotherapy; type of chemotherapy is not protocol-specified. Radiation, hormonal therapy, and trastuzumab are given as appropriate. The primary endpoint is disease-free survival (DFS). Quality-of-life measurements are collected at baseline, and then at 9 and 12 months. The accrual goal is 977 patients.

Results

This report describes the characteristics of the first 99 patients. Sites of recurrence at study entry were: breast (56%), mastectomy scar/chest wall (35%), and regional lymph nodes (9%). Two-thirds of patients have estrogen-receptor-positive recurrences.

Conclusion

This is the only trial actively investigating the question of “adjuvant” chemotherapy in locally recurrent breast cancer. The case mix of accrual to date indicates a broad representation of this patient population.

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Acknowledgements

The authors would like to thank the participating centers, including the Dutch Breast Cancer Trialists’ Group (BOOG), the Spanish Breast Cancer Research Group (GEICAM), the International Breast Cancer Study Group (IBCSG), and the National Surgical Adjuvant Breast and Bowel Project (NSABP). The authors would also like to thank Karen Price, Director of Scientific Administration for the International Breast Cancer Study Group (IBCSG). Supported in part by Public Health Service Grants U10CA-12027, U10CA-69974, U10CA-37377, and U10CA-69651 from the National Cancer Institute, Department of Health and Human Services. The International Breast Cancer Study Group is supported in part by the Swiss Group for Clinical Cancer Research (SAKK), the Frontier Science and Technology Research Foundation, the Cancer Council Australia, the Australian New Zealand Breast Cancer Trials Group, the National Cancer Institute (CA-75362), the Swedish Cancer Society, Cancer Research Switzerland/Oncosuisse, the Cancer Association of South Africa, and the Foundation for Clinical Research of Eastern Switzerland (OSKK).

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Correspondence to Irene L. Wapnir MD.

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Wapnir, I.L., Aebi, S., Gelber, S. et al. Progress on BIG 1-02/IBCSG 27-02/NSABP B-37, a Prospective Randomized Trial Evaluating Chemotherapy after Local Therapy for Isolated Locoregional Recurrences of Breast Cancer. Ann Surg Oncol 15, 3227–3231 (2008). https://doi.org/10.1245/s10434-008-0129-2

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  • DOI: https://doi.org/10.1245/s10434-008-0129-2

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