Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer (AMAROS)
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| ClinicalTrials.gov Identifier: NCT00014612 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : October 29, 2013
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RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be a less invasive treatment and cause fewer side effects than complete axillary lymph node dissection. It is not yet known which treatment is more effective for invasive breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of complete axillary lymph node dissection with that of axillary radiation therapy in treating women who have invasive breast cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Procedure: axillary lymph node dissection Procedure: lymphoscintigraphy Procedure: therapeutic conventional surgery Radiation: radiation therapy | Phase 3 |
OBJECTIVES:
- Compare the regional control of the axilla obtained by complete axillary lymph node dissection vs axillary radiotherapy in sentinel lymph node-positive women with operable invasive breast cancer.
- Determine whether local and regional axillary control can be obtained without axillary lymph node dissection in sentinel lymph node-negative women.
- Compare the axillary 5-year recurrence-free survival of these patients treated with these regimens.
- Compare the morbidity of patients treated with these regimens.
- Compare the quality of life of these patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center and type of breast surgery (conservation vs total mastectomy). Patients are randomized to 1 of 2 treatment arms.
Patients are given an injection of a tracer and undergo lymphoscintigraphy 2-3 hours later to identify the sentinel lymph node. Within 24 hours after lymphoscintigraphy, patients undergo wide local excision of the tumor or mastectomy after the sentinel node is removed. If no sentinel node is found or metastasis is found in a nonsentinel node, patients undergo complete axillary lymph node dissection (ALND) regardless of randomization. Sentinel node-negative patients receive no further treatment. Sentinel node-positive patients continue treatment according to randomization.
- Arm I: Within 8 weeks after surgery, patients undergo complete ALND.
- Arm II: Within 8 weeks after surgery, patients undergo axillary lymph node radiotherapy daily 5 days a week for 5 weeks.
Patients in arm I may receive postoperative axillary irradiation if 4 or more nodes are positive and more than 1 axillary level is involved.
Quality of life is assessed at baseline and then at 1, 2, 3, and 5 years.
Patients are followed annually for 5 years.
PROJECTED ACCRUAL: A total of 3,485 patients (1,394 sentinel node-positive and 2,091 sentinel node-negative) will be accrued for this study within 3 years.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 4813 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | After Mapping Of The Axilla: Radiotherapy Or Surgery |
| Study Start Date : | February 2001 |
| Actual Primary Completion Date : | November 2010 |
| Actual Study Completion Date : | March 2013 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: axillary lymph node dissection
complete axillary lymph node dissection
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Procedure: axillary lymph node dissection Procedure: lymphoscintigraphy Procedure: therapeutic conventional surgery |
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Experimental: axillary radiotherapy
axillary radiotherapy, daily for 5 days a week, for 5 weeks
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Procedure: lymphoscintigraphy Procedure: therapeutic conventional surgery Radiation: radiation therapy |
- Axillary recurrence rate [ Time Frame: from randomization ]
- Shoulder function as assessed by arm function test questionnaire at baseline, 1, 3, and 5 years after surgery [ Time Frame: from randomization ]
- Quality of life as measured by Quality of Life Questionnaire Core 30 Items (QLQ-C30) and QLQ-BR25 at baseline, 1, 2, 3, and 5 years after surgery [ Time Frame: from randomization ]
- Axillary recurrence-free survival [ Time Frame: from randomization ]
- Disease-free survival [ Time Frame: from randomization ]
- Overall survival [ Time Frame: from randomization ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically or "triple diagnosis" (palpation, mammogram or ultrasound, and cytology) confirmed operable invasive breast cancer
- T0-2, N0
- Diagnosis by excisional tumorectomy allowed
- Clinically occult invasive disease must be histologically confirmed
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Only 1 tumor in 1 breast
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Tumor between 5 and 50 mm in largest diameter, within 1 quadrant by mammogram, ultrasound or MRI
- Multifocal (i.e., within one quadrant and sharing the same histological characteristics) is allowed
- Multicentric (i.e., in different quadrants) breast cancer is not allowed
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- Clinically negative axillary lymph nodes
- No metastatic disease
- No previous treatment of the primary breast tumor by neoadjuvant hormonal or systemic treatment
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Hormone receptor status:
- Not specified
PATIENT CHARACTERISTICS:
Age:
- Any age
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- Not specified
Hepatic:
- Not specified
Renal:
- Not specified
Other:
- Fit to undergo sentinel node biopsy, axillary clearance, breast surgery, and/or axillary radiotherapy
- No psychological, familial, sociological, or geographical condition that would preclude study compliance
- No other prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- No prior radiotherapy to axilla
Surgery:
- No prior surgery to axilla
Other:
- See Disease Characteristics
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014612
Show 29 study locations
| Study Chair: | Emiel JT Rutgers | The Netherlands Cancer Institute | |
| Study Chair: | Robert Mansel | Cardiff and Vale University Health Board - University Hospital of Wales, Cardiff | |
| Study Chair: | Cornelis Van De Velde | Leiden University Medical Centre, Leiden | |
| Study Chair: | Geertjan Van Tienhoven | Academisch Medisch Centrum - Universiteit van Amsterdam, Amsterdam |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00014612 |
| Other Study ID Numbers: |
EORTC-10981-22023 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | October 29, 2013 |
| Last Verified: | October 2013 |
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stage IA breast cancer stage IB breast cancer stage II breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |