A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, and NSABP B-37

Irene L. Wapnir, Stefan Aebi, Charles E. Geyer, David Zahrieh, Richard D. Gelber, Stewart J. Anderson, André Robidoux, Jürg Bernhard, Rudolf Maibach, Monica Castiglione-Gertsch, Alan S. Coates, Martine J. Piccart, Mark J. Clemons, Joseph E. Costantino, Norman Wolmark

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

In this phase III, multinational, randomized trial, the International Breast Cancer Study Group, Breast International Group, and the National Surgical Adjuvant Breast and Bowel Project will attempt to define the effectiveness of cytotoxic therapy for patients with locoregional recurrence of breast cancer. We will evaluate whether chemotherapy prolongs disease-free survival and, secondarily, whether its use improves overall survival and systemic disease-free survival. Quality of life measurements will be monitored during the first 12 months of the study. Women who have had a previous diagnosis of invasive breast cancer treated by mastectomy or breast-conserving surgery and who have undergone complete surgical excision of all macroscopic disease but who subsequently develop isolated local and/or regional ipsilateral invasive recurrence are eligible. Patients are randomized to observation/no adjuvant chemotherapy or to adjuvant chemotherapy; all suitable patients receive radiation, hormonal, and trastuzumab therapy. Radiation therapy is recommended for patients who have not received previous adjuvant radiation therapy but is required for those with microscopically positive margins. The radiation field must encompass the tumor bed plus a surrounding margin to a dose of ≥ 40 Gy. Radiation therapy will be administered before, during, or after chemotherapy. All women with estrogen receptor-positive and/or progesterone receptor-positive recurrence must receive hormonal therapy, with the agent and duration to be determined by the patient's investigator. Adjuvant trastuzumab therapy is permitted for those with HER2-positive tumors, provided that intent to treat is declared before randomization. Although multidrug regimens are preferred, the agents, doses, and use of supportive therapy are at the discretion of the investigator.

Original languageEnglish (US)
Pages (from-to)287-292
Number of pages6
JournalClinical Breast Cancer
Volume8
Issue number3
DOIs
StatePublished - 2008

Fingerprint

Adjuvant Chemotherapy
Randomized Controlled Trials
Breast Neoplasms
Recurrence
Radiotherapy
Disease-Free Survival
Breast
Research Personnel
Radiation
Therapeutics
Drug Therapy
Segmental Mastectomy
Mastectomy
Progesterone Receptors
Random Allocation
Estrogen Receptors
Neoplasms
Quality of Life
Observation
Survival

Keywords

  • Ipsilateral breast cancer
  • Radiation therapy
  • Recurrence

ASJC Scopus subject areas

  • Cancer Research

Cite this

A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer : IBCSG 27-02, BIG 1-02, and NSABP B-37. / Wapnir, Irene L.; Aebi, Stefan; Geyer, Charles E.; Zahrieh, David; Gelber, Richard D.; Anderson, Stewart J.; Robidoux, André; Bernhard, Jürg; Maibach, Rudolf; Castiglione-Gertsch, Monica; Coates, Alan S.; Piccart, Martine J.; Clemons, Mark J.; Costantino, Joseph E.; Wolmark, Norman.

In: Clinical Breast Cancer, Vol. 8, No. 3, 2008, p. 287-292.

Research output: Contribution to journalArticle

Wapnir, IL, Aebi, S, Geyer, CE, Zahrieh, D, Gelber, RD, Anderson, SJ, Robidoux, A, Bernhard, J, Maibach, R, Castiglione-Gertsch, M, Coates, AS, Piccart, MJ, Clemons, MJ, Costantino, JE & Wolmark, N 2008, 'A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, and NSABP B-37', Clinical Breast Cancer, vol. 8, no. 3, pp. 287-292. https://doi.org/10.3816/CBC.2008.n.035
Wapnir, Irene L. ; Aebi, Stefan ; Geyer, Charles E. ; Zahrieh, David ; Gelber, Richard D. ; Anderson, Stewart J. ; Robidoux, André ; Bernhard, Jürg ; Maibach, Rudolf ; Castiglione-Gertsch, Monica ; Coates, Alan S. ; Piccart, Martine J. ; Clemons, Mark J. ; Costantino, Joseph E. ; Wolmark, Norman. / A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer : IBCSG 27-02, BIG 1-02, and NSABP B-37. In: Clinical Breast Cancer. 2008 ; Vol. 8, No. 3. pp. 287-292.
@article{ecc91dfc3c3f46b78df1e8c8054e391f,
title = "A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer: IBCSG 27-02, BIG 1-02, and NSABP B-37",
abstract = "In this phase III, multinational, randomized trial, the International Breast Cancer Study Group, Breast International Group, and the National Surgical Adjuvant Breast and Bowel Project will attempt to define the effectiveness of cytotoxic therapy for patients with locoregional recurrence of breast cancer. We will evaluate whether chemotherapy prolongs disease-free survival and, secondarily, whether its use improves overall survival and systemic disease-free survival. Quality of life measurements will be monitored during the first 12 months of the study. Women who have had a previous diagnosis of invasive breast cancer treated by mastectomy or breast-conserving surgery and who have undergone complete surgical excision of all macroscopic disease but who subsequently develop isolated local and/or regional ipsilateral invasive recurrence are eligible. Patients are randomized to observation/no adjuvant chemotherapy or to adjuvant chemotherapy; all suitable patients receive radiation, hormonal, and trastuzumab therapy. Radiation therapy is recommended for patients who have not received previous adjuvant radiation therapy but is required for those with microscopically positive margins. The radiation field must encompass the tumor bed plus a surrounding margin to a dose of ≥ 40 Gy. Radiation therapy will be administered before, during, or after chemotherapy. All women with estrogen receptor-positive and/or progesterone receptor-positive recurrence must receive hormonal therapy, with the agent and duration to be determined by the patient's investigator. Adjuvant trastuzumab therapy is permitted for those with HER2-positive tumors, provided that intent to treat is declared before randomization. Although multidrug regimens are preferred, the agents, doses, and use of supportive therapy are at the discretion of the investigator.",
keywords = "Ipsilateral breast cancer, Radiation therapy, Recurrence",
author = "Wapnir, {Irene L.} and Stefan Aebi and Geyer, {Charles E.} and David Zahrieh and Gelber, {Richard D.} and Anderson, {Stewart J.} and Andr{\'e} Robidoux and J{\"u}rg Bernhard and Rudolf Maibach and Monica Castiglione-Gertsch and Coates, {Alan S.} and Piccart, {Martine J.} and Clemons, {Mark J.} and Costantino, {Joseph E.} and Norman Wolmark",
year = "2008",
doi = "10.3816/CBC.2008.n.035",
language = "English (US)",
volume = "8",
pages = "287--292",
journal = "Clinical Breast Cancer",
issn = "1526-8209",
publisher = "Elsevier",
number = "3",

}

TY - JOUR

T1 - A randomized clinical trial of adjuvant chemotherapy for radically resected locoregional relapse of breast cancer

T2 - IBCSG 27-02, BIG 1-02, and NSABP B-37

AU - Wapnir, Irene L.

AU - Aebi, Stefan

AU - Geyer, Charles E.

AU - Zahrieh, David

AU - Gelber, Richard D.

AU - Anderson, Stewart J.

AU - Robidoux, André

AU - Bernhard, Jürg

AU - Maibach, Rudolf

AU - Castiglione-Gertsch, Monica

AU - Coates, Alan S.

AU - Piccart, Martine J.

AU - Clemons, Mark J.

AU - Costantino, Joseph E.

AU - Wolmark, Norman

PY - 2008

Y1 - 2008

N2 - In this phase III, multinational, randomized trial, the International Breast Cancer Study Group, Breast International Group, and the National Surgical Adjuvant Breast and Bowel Project will attempt to define the effectiveness of cytotoxic therapy for patients with locoregional recurrence of breast cancer. We will evaluate whether chemotherapy prolongs disease-free survival and, secondarily, whether its use improves overall survival and systemic disease-free survival. Quality of life measurements will be monitored during the first 12 months of the study. Women who have had a previous diagnosis of invasive breast cancer treated by mastectomy or breast-conserving surgery and who have undergone complete surgical excision of all macroscopic disease but who subsequently develop isolated local and/or regional ipsilateral invasive recurrence are eligible. Patients are randomized to observation/no adjuvant chemotherapy or to adjuvant chemotherapy; all suitable patients receive radiation, hormonal, and trastuzumab therapy. Radiation therapy is recommended for patients who have not received previous adjuvant radiation therapy but is required for those with microscopically positive margins. The radiation field must encompass the tumor bed plus a surrounding margin to a dose of ≥ 40 Gy. Radiation therapy will be administered before, during, or after chemotherapy. All women with estrogen receptor-positive and/or progesterone receptor-positive recurrence must receive hormonal therapy, with the agent and duration to be determined by the patient's investigator. Adjuvant trastuzumab therapy is permitted for those with HER2-positive tumors, provided that intent to treat is declared before randomization. Although multidrug regimens are preferred, the agents, doses, and use of supportive therapy are at the discretion of the investigator.

AB - In this phase III, multinational, randomized trial, the International Breast Cancer Study Group, Breast International Group, and the National Surgical Adjuvant Breast and Bowel Project will attempt to define the effectiveness of cytotoxic therapy for patients with locoregional recurrence of breast cancer. We will evaluate whether chemotherapy prolongs disease-free survival and, secondarily, whether its use improves overall survival and systemic disease-free survival. Quality of life measurements will be monitored during the first 12 months of the study. Women who have had a previous diagnosis of invasive breast cancer treated by mastectomy or breast-conserving surgery and who have undergone complete surgical excision of all macroscopic disease but who subsequently develop isolated local and/or regional ipsilateral invasive recurrence are eligible. Patients are randomized to observation/no adjuvant chemotherapy or to adjuvant chemotherapy; all suitable patients receive radiation, hormonal, and trastuzumab therapy. Radiation therapy is recommended for patients who have not received previous adjuvant radiation therapy but is required for those with microscopically positive margins. The radiation field must encompass the tumor bed plus a surrounding margin to a dose of ≥ 40 Gy. Radiation therapy will be administered before, during, or after chemotherapy. All women with estrogen receptor-positive and/or progesterone receptor-positive recurrence must receive hormonal therapy, with the agent and duration to be determined by the patient's investigator. Adjuvant trastuzumab therapy is permitted for those with HER2-positive tumors, provided that intent to treat is declared before randomization. Although multidrug regimens are preferred, the agents, doses, and use of supportive therapy are at the discretion of the investigator.

KW - Ipsilateral breast cancer

KW - Radiation therapy

KW - Recurrence

UR - http://www.scopus.com/inward/record.url?scp=46949089752&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=46949089752&partnerID=8YFLogxK

U2 - 10.3816/CBC.2008.n.035

DO - 10.3816/CBC.2008.n.035

M3 - Article

C2 - 18650162

AN - SCOPUS:46949089752

VL - 8

SP - 287

EP - 292

JO - Clinical Breast Cancer

JF - Clinical Breast Cancer

SN - 1526-8209

IS - 3

ER -