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American College of Surgeons Oncology Group (ACOSOG)

Published online by Cambridge University Press:  04 December 2006

Abstract

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by American College of Surgeons Oncology Group (ACOSOG). Clinical trials include:

  1. ACOSOG Z1031: A randomized phase III trial comparing 16–18 weeks of neoadjuvant exemestane (25mg daily), letrozole (2.5mg), or anastrozole (1mg) in postmenopausal women with clinical stages II and III estrogen receptor positive breast cancer.

  2. ACOSOG Z0010: A prognostic study of sentinel node and bone marrow micrometastases in women with clinical T1 or T2 N0 M0 breast cancer.

  3. ACOSOG Z0011: A randomized trial of axillary node dissection in women with clinical T1–2 N0 M0 breast cancer who have a positive sentinel node.

ACOSOG – Contact Details

Country

USA

Chairs

D.M. Ota, Duke Clinical Research Institute/ACOSOG, 2400 Pratt St., Terrace Level Room 0311, Durham, NC 27705, USA. Tel: +1 919 668 5987 Fax: +1 919 668 7123/7156 Email:

H. Nelson, Fred C. Anderson Professor of Surgery, Mayo Clinic College of Medicine, 200 First St., SW, Rochester, MN 55905, USA. Tel: +1 507 284 2511 Fax: +1 507 284 1794 Email:

Other Subgroup Head/Member

Breast Committee, Chair Breast Organ Site Committee: K.K. Hunt, Professor of Surgery, Chief Surgical Breast Section, The University of Texas M.D. Anderson Cancer Center, Chief Surgical Breast Section, Department of Surgical Oncology, 1515 Holcombe Boulevard, Unit 444, Houston, TX 77030, USA. Tel: +1 713 792 7216 Fax: +1 713 792 4689 Email:

Other Subgroup Head/Member

Vice Chairs Breast Organ Site Committee: A.M. Leitch, Professor of Surgery, University of Texas Southwestern Medical Center, 5323 Harry Hines Blvd., Dallas, TX 75390-9155, USA. Tel: +1 214 648 3039 Fax: +1 214 648 8695 Email:

R.M. Simmons, A.K. and E.C. Weiskopf Associate Professor of Surgical Oncology, Joan and Sanford Weill Medical College of Cornell University, Department of Surgical Oncology, The New York Presbyterian Hospital, Iris Cantor Women's Health Center, 425 East 61st St., 8th Floor, New York, NY 10021, USA. Tel: +1 212 821 0870 Fax: +1 212 821 0832 Email:

P.W. Whitworth, Vanderbilt University, Nashville Breast Center, Department of Surgery, Suite 401, 300 20th Avenue North, Nashville, TN 37203, USA. Tel: +1 615 284 8229 Fax: +1 615 284 7794 Email:

Other Subgroup Head/Member

Group Administrator: B. Martinez, Tel: +1 919 668 8451 Email:

Other Subgroup Head/Member

Clinical Trials Assistant: Susan Schwab, Tel: +1 919 668 8987 Email:

ACOSOG – Study Details

Title

ACOSOG Z1031: A randomized phase III trial comparing 16–18 weeks of neoadjuvant exemestane (25mg daily), letrozole (2.5mg), or anastrozole (1mg) in postmenopausal women with clinical stages II and III estrogen receptor positive breast cancer.

Coordinator(s)

K.S. Ross, Duke University Medical Center (DUMC), American College of Surgeons Oncology Group (ACOSOG), Duke Clinical Research Institute (DCRI), USA. Tel: +1 919 668 8812 Fax: +1 919 668 7122 Email:

Principal Investigators

M.J. Ellis, Barnes Jewish Hospital, 660 S. Euclid, Box 8056, St Louis, MO 63110, USA. Tel: +1 314 362 8866 Fax: +1 314 362 7086 Email:

J.A. Olson Jr, Duke University Medical Center, Department of Surgery, Box 3873, Durham, NC 27710, USA. Tel: +1 919 684 6523 Fax: +1 919 681 6291 Email:

Summary

  • Opened in March 2006
  • Target accrual: 375 patients

Primary Objective

To determine whether anastrozole, exemestane or letrozole administered for 16–18 weeks as neoadjuvant endocrine treatment for postmenopausal patients with stage II or III ER + breast cancer should be chosen as the aromatase inhibitor of a future study that will compare a neoadjuvant aromatase inhibitor treatment with neoadjuvant chemotherapy.

Secondary Objectives

  • To compare the neoadjuvant treatment regimens relative to the rates of improvement in surgical outcome defined as follows:

        – For T4 a, b, c tumors: mastectomy with primary skin closure and negative surgical margins.

        – For T3 and T2 tumors classified as requiring mastectomy at baseline: breast conserving surgery with negative final margins.

        – For T2 tumors classified as potential candidates for breast conservation: wide excision at first attempt.

  • To compare the radiological response rates (mammography and ultrasound by central radiological analysis) between these three neoadjuvant treatment regimens.
  • To compare the relative safety of the neoadjuvant treatment regimens in terms of reported adverse events.

Scheme

Z1031: A randomized phase III trial comparing 16–18 weeks of neoadjuvant exemestane (25 mg daily), letrozole (2.5 mg daily) or anastrozole (1 mg daily), in postmenopausal women with clinical stage II or III estrogen receptor postive breast cancer

Update

Total accrual: 21 patients as of September 25, 2006.

Related Publications

None available

Topics

  • Aromatase inhibitors
  • Breast conservative treatment
  • Hormonal therapy
  • Hormone receptor positive breast cancer
  • Postmenopausal patients

Keywords

Neoadjuvant endocrine therapy, estrogen receptor positive breast cancer

***************************************************

Title

ACOSOG Z0010: A prognostic study of sentinel node and bone marrow micrometastases in women with clinical T1 or T2 N0 M0 breast cancer.

Coordinator(s)

K.S. Ross, Duke University Medical Center (DUMC), American College of Surgeons Oncology Group (ACOSOG), Duke Clinical Research Institute (DCRI), USA. Tel: +1 919 668 8812 Fax: +1 919 668 7122 Email:

Principal Investigator

A.E. Giuliano, John Wayne Cancer Institute, 2200 Santa Monica Boulevard, Suite 113, Santa Monica, CA 90404-2302, USA. Tel: +1 310 829 8089 Fax: +1 310 998 3995 Email:

Summary

  • Opened in May 1999
  • Target accrual: 5300 patients

Primary and Secondary Objectives

  • To estimate the prevalence and to evaluate the prognostic significance of sentinel node micrometastases detected by immunohistochemistry (IHC).
  • To estimate the prevalence and to evaluate the prognostic significance of bone marrow micrometastasis detected by immunocytochemistry (ICC).
  • To evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H&E) staining.
  • To provide a mechanism for identifying women whose sentinel nodes contain metastases detected by H&E so that these women can be considered as candidates for Study Z0011.

Scheme

Update

  • Study closed in May 2003 with 5539 patients.
  • Five-year results have not yet been published.

Related Publications

Leitch AM, et al. Patterns of participation and successful patient recruitment to ACOSOG Z0010, a phase II trial for patients with early stage breast cancer. Am J Surg 2005; 190(4): 539–542.

Posther KE, et al. Sentinel node skills verification and surgeon performance: data from a multicenter clinical trial for early stage breast cancer. Ann Surgery 2005; 242(4): 593–599; discussion 599–602.

Wilke LG, et al. Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperative group trial. Ann Surg Oncol 2006; 13(4): 491–500.

Topics

  • Bone marrow micrometastasis
  • Breast conservative treatment
  • Loco-regional relapse
  • Node negative breast cancer
  • Prognostic factors
  • Sentinel node micrometastasis
  • Sentinel node resection

Keywords

Sentinel lymph node biopsy, bone marrow micrometastases, immunohistochemistry

***************************************************

Title

ACOSOG Z0011: A randomized trial of axillary node dissection in women with clinical T1–2 N0 M0 breast cancer who have a positive sentinel node.

Coordinator(s)

K.S. Ross, Duke University Medical Center (DUMC), American College of Surgeons Oncology Group (ACOSOG), Duke Clinical Research Institute (DCRI), USA. Tel: +1 919 668 8812 Fax: +1 919 668 7122 Email:

Principal Investigator

A.E. Giuliano, John Wayne Cancer Institute, 2200 Santa Monica Boulevard, Suite 113, Santa Monica, CA 90404-2302, USA. Tel: +1 310 829 8089 Fax: +1 310 998 3995 Email:

Summary

  • Opened in May 1999
  • Target accrual: 1900 patients

Objectives

  • Long term: To assess whether overall survival for patients randomized to Arm 2 (no immediate axillary lymph node dissection, ALND) is essentially equivalent to (or better than) that for patients assigned to Arm 1 (completion ALND).
  • Short term: To quantify and compare the surgical morbidities associated with sentinel lymph node dissection (SLND) plus ALND versus SLND alone.

Scheme

Update

  • The study closed in 15/12/2004 secondary to slow accrual with 891 patients.

Related Publications

Lucci A, et al. Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection, versus SLND alone in the American College of Surgeons Oncology Group (ACOSOG) Trial Z0011. Ann Surg Oncol 2006; 13(2): 4.

Topics

  • Axillary lymph node dissection
  • Breast conservative treatment
  • Loco-regional relapse
  • Node positive breast cancer
  • Sentinel node micrometastasis
  • Sentinel node resection

Keywords

Sentinel node biopsy, surgical morbidity, lymphedema