Clinical trial · Interventional
Radiation Therapy in Treating Women Who Have Undergone Surgery for Early-Stage Invasive Breast Cancer
A Phase III Study of Regional Radiation Therapy in Early Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiation to the tumor site and surrounding area may kill more tumor cells. It is not yet known if radiation therapy to the breast alone following surgery is more effective than radiation therapy to the breast plus surrounding tissue in treating invasive breast cancer. PURPOSE: This randomized phase III trial is studying radiation therapy to the breast alone to see how well it works compared to radiation therapy to the breast plus surrounding tissue in treating women who have undergone surgery for early-stage invasive breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Radiation plus Regional Radiation | Radiation | — | UNRESOLVED |
| Standard Breast Irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Breast Irradiation
- interventionNames
- Radiation: Standard Breast Irradiation
- type
- EXPERIMENTAL
- label
- Breast Radiation plus regional radiation
- description
- regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)
- interventionNames
- Radiation: Breast Radiation plus Regional Radiation
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 10 years
- description
- Duration of study
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically proven invasive carcinoma of the breast
* No evidence of T4, N2-3, or M1 disease prior to surgery
* Node positive or high-risk node negative
* Prior breast-conserving therapy (BCT) (e.g., lumpectomy, partial mastectomy, or segmental mastectomy) and axillary node dissection or sentinel node biopsy required and must be a candidate for breast radiotherapy after BCT
* Normally patients should have microscopically clear resection margins and those with positive margins should undergo reexcision
* Patients with microscopically focally positive margins (defined as no greater than 3 times high power fields) are candidates for breast radiotherapy plus a boost to the lumpectomy site
* Patients with prior sentinel node dissection eligible if node negative, but still meet high-risk criteria
* If node positive, then a level I and II axillary dissection must be performed
* No evidence of residual disease in axilla after dissection
* Must be treated with currently accepted adjuvant systemic chemotherapy and/or hormonal therapy
* High risk of regional and systemic recurrence due to one of the following:
* Pathologically positive axillary lymph nodes
* Pathologically negative axillary lymph nodes with one of the following:
* Primary tumor greater than 5 cm
* Primary tumor greater than 2 cm and less than 10 axillary lymph nodes excised and one of the following:
* Estrogen receptor negative
* Skarf-Bloom-Richardson grade 3
* Lymphovascular invasion
* Hormone receptor status:
* Estrogen and progesterone receptor status known
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Sex:
* Female
Menopausal status:
* Premenopausal or postmenopausal
Performance status:
* ECOG 0-2
Life expectancy:
* At least 5 years
Hematopoietic:
* Not specified
Hepatic:
* SGOT and/or SGPT no greater than 3 times upper limit of normal (ULN)\*
* Alkaline phosphatase no greater than 3 times ULN\* NOTE: \* Patients with laboratory values greater than 3 times ULN may still be eligible if no metastatic disease by imaging examinations
Renal:
* No serious nonmalignant renal disease
Cardiovascular:
* No serious nonmalignant cardiovascular disease
Pulmonary:
* No serious nonmalignant pulmonary disease
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other serious nonmalignant disease (e.g., systemic lupus erythematosus or scleroderma) that would preclude definitive surgery or radiotherapy
* No other malignancy except:
* Nonmelanomatous skin cancer
* Carcinoma in situ of the cervix or endometrium
* Contralateral noninvasive breast cancer (unless prior radiotherapy to the contralateral breast)
* Invasive carcinoma of the cervix, endometrium, colon, thyroid, or melanoma that was curatively treated at least 5 years prior to study participation
* No psychiatric or addictive disorder that would preclude informed consent or study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* See Disease Characteristics
* Concurrent standard adjuvant chemotherapy allowed
Endocrine therapy:
* See Disease Characteristics
* Concurrent standard adjuvant hormonal therapy allowed
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease CharacteristicsReferences
Publications (2)
- RESULTWhelan TJ, Olivotto IA, Parulekar WR, Ackerman I, Chua BH, Nabid A, Vallis KA, White JR, Rousseau P, Fortin A, Pierce LJ, Manchul L, Chafe S, Nolan MC, Craighead P, Bowen J, McCready DR, Pritchard KI, Gelmon K, Murray Y, Chapman JA, Chen BE, Levine MN; MA.20 Study Investigators. Regional Nodal Irradiation in Early-Stage Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):307-16. doi: 10.1056/NEJMoa1415340. PMID 26200977
- DERIVEDGross JP, Whelan TJ, Parulekar WR, Chen BE, Rademaker AW, Helenowski IB, Donnelly ED, Strauss JB. Development and Validation of a Nomogram to Predict Lymphedema After Axillary Surgery and Radiation Therapy in Women With Breast Cancer From the NCIC CTG MA.20 Randomized Trial. Int J Radiat Oncol Biol Phys. 2019 Sep 1;105(1):165-173. doi: 10.1016/j.ijrobp.2019.05.002. Epub 2019 May 11. PMID 31085285