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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00002528
First received: November 1, 1999
Last updated: April 3, 2013
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: tamoxifen citrate
Procedure: conventional surgery
Radiation: radiation therapy
Procedure: Axillary clearance
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Surgical Therapy With or Without Axillary Node Clearance for Breast Cancer in the Elderly Who Receive Adjuvant Therapy With Tamoxifen.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by International Breast Cancer Study Group:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: 17 years from randomization ] [ Designated as safety issue: No ]
    Time from randomization to recurrence, metastasis, appearance of a second primary tumor, or death from any cause, whichever occurs first.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: 17 years from randomization ] [ Designated as safety issue: No ]
    Time from randomization to death.

  • Toxicity [ Time Frame: 17 years from randomization ] [ Designated as safety issue: Yes ]
    Side effects of treatment, especially surgery-related events.

  • Quality of life [ Time Frame: 17 years from randomization ] [ Designated as safety issue: No ]
    Quality of life will be assessed by standard International Breast Cancer Study Group instruments


Enrollment: 473
Study Start Date: May 1993
Study Completion Date: August 2010
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 Drug: tamoxifen citrate
20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.
Procedure: conventional surgery
Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).
Radiation: radiation therapy
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.
Procedure: Axillary clearance
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.
 Drug: tamoxifen citrate
20 mg daily beginning within 6 weeks of surgery for 5 years or until relapse, whichever occurs first.
Procedure: conventional surgery
Either total mastectomy or, optionally if the tumor was smaller than 5 cm, a breast conserving procedure (lumpectomy or quadrantectomy).
Radiation: radiation therapy
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.

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002528

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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00002528     History of Changes
Other Study ID Numbers: CDR0000078383, IBCSG-10-93, EU-93013, NCI-F93-0008
Study First Received: November 1, 1999
Last Updated: April 3, 2013
Health Authority: United States: Federal Government
Switzerland: Swissmedic

Keywords provided by International Breast Cancer Study Group:
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on May 19, 2013