Clinical trial · Interventional
Radiation Therapy in Treating Women With Early Stage Breast Cancer
Safety and Feasibility of Accelerated, Hypofractionated Radiotherapy in Women With Breast Cancer: A Phase II Trial
NCT00909909CI-TRIAL-00068475active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage 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 |
|---|---|---|---|
| External beam boost | Radiation | — | UNRESOLVED |
| whole breast irradiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- 3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI)
- interventionNames
- Radiation: External beam boost
- Radiation: whole breast irradiation
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Accelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost
- interventionNames
- Radiation: External beam boost
- Radiation: whole breast irradiation
Primary outcomes (1)
- measure
- Loco-regional control as assessed by physical examination, mammography, and other relevant imaging
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer, including 1 of the following subtypes: * Ductal carcinoma in situ * Invasive ductal carcinoma * Invasive lobular carcinoma * Medullary carcinoma * Papillary carcinoma * Colloidal (mucinous) carcinoma * Tubular carcinoma * Pathological stage 0-IIIA disease (pTis; pT1-2, N0-N2a, M0) * Tumor size ≤ 5 cm * Breast considered technically satisfactory for radiotherapy * Has undergone lumpectomy or mastectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present) * Negative inked histological margins (i.e., no invasive cells at surgical margin) or confirmed negative re-excision specimen * Unifocal or multifocal (confined to 1 quadrant; tumors \< 4 cm apart) disease with 1 or 2 foci that can be encompassed by 1 lumpectomy * No proven multicentric carcinoma (tumors in different quadrants of the breast or tumor separated by ≥ 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy * No evidence of suspicious microcalcifications in the breast before the start of radiotherapy * If malignancy-associated microcalcifications were initially present, the post-excision mammography must be negative * No more than 9 positive axillary lymph nodes * No palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor * No previously treated contralateral breast cancer or synchronous ipsilateral breast cancer * No lobular carcinoma in situ alone (i.e., no invasive component) or non-epithelial breast malignancies (e.g., sarcoma or lymphoma) * No Paget disease of the nipple * No skin involvement, regardless of tumor size * No distant metastases * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Pre- or post-menopausal * ECOG performance status 0-1 * No co-existing medical condition that would limit life expectancy to \< 2 years * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except for nonmelanoma skin cancer (the disease-free interval from any prior malignancy must be continuous) * No collagen vascular disease, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis * No psychiatric or addictive disorder that would preclude obtaining informed consent PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy for the current breast cancer * No tylectomies so extensive that the cosmetic result is low or poor prior to radiotherapy * Chemotherapy allowed provided the following criteria are met: * Chemotherapy is not administered prior to, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving brachytherapy boost) * Chemotherapy is not administered for ≥ 21 days before, during, and for ≥ 21 days after completion of radiotherapy (for patients receiving external beam radiotherapy boost or chest wall irradiation) * Concurrent tamoxifen, anastrozole, or other hormonal therapy allowed * May be initiated before, during, or after radiotherapy * No other concurrent chemotherapy, immunotherapy, or experimental medications
References
Publications (2)
- DERIVEDChakraborty MA, Sherwani ZK, Narra LR, Abou Yehia Z, Ohri N, Cui T, Eladoumikdachi F, Kowzun MJ, Kumar S, Potdevin L, Toppmeyer DL, Haffty BG. Preoperative Radiation Boost Results in Low Rates of Re-excision and Reduced Locoregional Treatment Time in Breast Cancer Patients. Ann Surg Oncol. 2025 Dec;32(13):9836-9842. doi: 10.1245/s10434-025-18089-9. Epub 2025 Aug 20. PMID 40836156
- DERIVEDAhlawat S, Haffty BG, Goyal S, Kearney T, Kirstein L, Chen C, Moore DF, Khan AJ. Short-Course Hypofractionated Radiation Therapy With Boost in Women With Stages 0 to IIIa Breast Cancer: A Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2016 Jan 1;94(1):118-125. doi: 10.1016/j.ijrobp.2015.09.011. Epub 2015 Sep 16. PMID 26700706