Surgery With or Without Lymph Node Removal in Treating Older Women With Stage I or Stage IIA Breast Cancer (10-93)

April 3, 2013 updated by: ETOP IBCSG Partners Foundation

Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.

RATIONALE: Removing axillary lymph nodes may be effective in stopping the spread of breast cancer cells. It is not yet known if surgery to remove breast cancer is more effective with or without lymph node removal.

PURPOSE: Randomized phase III trial to compare the effectiveness of breast surgery with or without removal of axillary lymph nodes in treating women who have stage I or stage IIA breast cancer.

Study Overview

Detailed Description

OBJECTIVES:

  • Compare local and systemic disease-free survival, ipsilateral axillary relapse, occurrence of postmastectomy syndrome, and overall survival of elderly women with clinically operable stage I or IIA breast cancer who subsequently receive adjuvant tamoxifen after treatment with breast surgery with or without axillary node dissection.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to whether they received prior primary surgery (yes vs no) and participating center.

  • Arm I: Patients undergo mastectomy, lumpectomy, or quadrantectomy with axillary clearance. Patients then receive oral tamoxifen for 5 years. Patients may also undergo sentinel node biopsy.
  • Arm II: Patients undergo surgery as in arm I without axillary clearance. Patients then receive oral tamoxifen for 5 years.

Patients in both arms who undergo breast-conserving surgery may receive optional radiotherapy for 5-6 weeks to the remaining breast tissue, chest, and lung. Upon recurrence in the conserved breast, patients undergo total mastectomy; those in arm II who experience ipsilateral axillary recurrence undergo surgical excision. Adjuvant tamoxifen and follow up are continued.

Quality of life is assessed.

Patients are followed every 3 months for 1 year, every 6 months while receiving tamoxifen, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,020 patients will be accrued for this study within approximately 5 years.

Study Type

Interventional

Enrollment (Actual)

473

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital, Sydney
      • Waratah, New South Wales, Australia, 2298
        • Newcastle Mater Misericordiae Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Anti-Cancer Council of Victoria, Melbourne
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital, Perth
      • Budapest, Hungary, 1125
        • National Institute of Oncology
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico - Aviano
      • Brescia, Italy, 25124
        • Spedali Civili
      • Gorizia, Italy, 34170
        • Presidio Ospedaliero-Gorizia
      • Rimini, Italy, 47900
        • Ospedale Civile Rimini
      • Rome, Italy, 00144
        • Ospedale San Eugenio
      • Auckland, New Zealand, 5
        • Auckland Adventist Hospital
      • Ljubljana, Slovenia, Sl-1000
        • Institute of Oncology, Ljubljana
      • Cape Town, South Africa, 7925
        • Groote Schuur Hospital, Cape Town
      • Gothenburg (Goteborg), Sweden, S-413 45
        • Sahlgrenska University Hospital
      • Basel, Switzerland, CH-4031
        • University Hospital
      • Bern, Switzerland, CH-3010
        • Inselspital, Bern
      • Lausanne, Switzerland, CH-1011
        • Centre Hospitalier Universitaire Vaudois
      • St. Gallen, Switzerland, CH-9006
        • Kantonsspital - St. Gallen
      • Zurich, Switzerland, CH-8091
        • UniversitaetsSpital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage I or IIA breast carcinoma that is considered operable
  • No prior axillary clearance or biopsy
  • Complete excisional biopsy of primary tumor without axillary clearance or biopsy allowed
  • Suspicious manifestations of metastatic disease (e.g., hot spots on bone scan or skeletal pain of unknown cause) must be proven benign
  • No bilateral breast cancer (any mass in contralateral breast must be proven benign by biopsy)
  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 60 and over

Sex:

  • Female

Menopausal status

  • Postmenopausal

Performance status:

  • Not specified

Hematopoietic:

  • WBC greater than 4,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.1 mg/dL
  • AST less than 60 U/L

Renal:

  • Creatinine less than 1.3 mg/dL

Cardiovascular:

  • Normal cardiac function
  • No history of congestive heart failure

Other:

  • No nonmalignant systemic disease that would preclude protocol therapy or prolonged follow-up
  • No psychiatric or addictive disorder that would preclude protocol therapy or informed consent
  • No other prior or concurrent malignancy except nonmelanomatous skin cancer or adequately treated carcinoma in situ of the cervix
  • Geographically accessible for follow-up

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for breast cancer

Chemotherapy:

  • No prior chemotherapy for breast cancer

Endocrine therapy:

  • No prior endocrine therapy for breast cancer

Radiotherapy:

  • No prior radiotherapy for breast cancer

Surgery:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery w/ axillary clearance, tamox
Either a total mastectomy with axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) with axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.
20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.
Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).
No radiotherapy is to be given after mastectomy. Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution. It should be given to the breast only and not to the draining node areas.
Axillary node dissection.
Experimental: Surgery w/o axillary clearance, tamox
Either a total mastectomy without axillary clearance, or a lesser procedure (quadrantectomy or lumpectomy with radiotherapy to the conserved breast) without axillary lymph node dissection, and tamoxifen (20 mg) given after surgery for the duration of 5 years or until relapse.
20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.
Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).
No radiotherapy is to be given after mastectomy. Radiotherapy is optional after breast conserving surgery according to prospectively determined guidelines within each institution. It should be given to the breast only and not to the draining node areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival
Time Frame: 17 years from randomization
Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.
17 years from randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 17 years from randomization
Time from randomization to death.
17 years from randomization
Toxicity
Time Frame: 17 years from randomization
Side effects of treatment, especially surgery-related events.
17 years from randomization
Quality of life
Time Frame: 17 years from randomization
Quality of life will be assessed by standard International Breast Cancer Study Group instruments
17 years from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Diana Crivellari, MD, Centro di Riferimento Oncologico - Aviano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1993

Primary Completion (Actual)

December 1, 2002

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 3, 2013

Last Verified

July 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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