Clinical trial · Interventional
Partial Breast Irradiation With Chemotherapy
Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy
NCT00278109CI-TRIAL-00043503completedPhase 1 / Phase 2Results postedClinicalTrials.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. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cyclophosphamide and doxorubicin after surgery may kill any tumor cells that remain. PURPOSE: This phase I/II trial is studying the side effects of radiation therapy when given together with cyclophosphamide and doxorubicin and to see how well they work in treating women with stage I or stage II breast cancer who have undergone surgery.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| radiation | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PBI with Concurrent Chemotherapy
- description
- Phase I Single Arm study of PBI with concurrent chemotherapy. Primary endpoint is radiation toxicity. The intervention is partial breast radiation with doxorubicin and cyclophosphamide.
- interventionNames
- Drug: cyclophosphamide
- Drug: Doxorubicin
- Radiation: radiation
Primary outcomes (1)
- measure
- Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity
- timeFrame
- up to 5 years
- description
- Number of participants with Grade 4 toxicity as defined by the following criteria: Acute Skin Toxicity: 0=No change, 1= Follicular, faint, or dull erythema/epilation/dry/desquamation/decreased swelling, 2= Tender or bright erythemal patchy moist desquamation/moderate edema, 3= Confluent moist desquamation other than skin folds, piting edema, 4= Ulceration, hemorrahage, necrosis, Late Skin Toxicity: 0= None, 1= Slight Atrophy, Pigmentation change, some hair loss, 2= Patch atrophy, moderate telangectasias, total hair loss, 3= Marked atrophy, gross telangectasias, 4= Ulceration; Subcutaneous Tissue Toxicity: 0= None, 1= Slight induration (fibrosis) and loss of subcutaneous fat, 2= Moderate fibrosis but asymptomatic; slight field contracture; \<10% linear reduction, 3= Severe induration and loss subcutaneous tissue; field contracture \>10% linear reduction; 4= Necrosis
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed adenocarcinoma of the breast by routine hematoxylin and eosin (H\&E) staining
* Primary tumor ≤ 4 cm and 0-3 positive axillary lymph nodes (pathologic T1-2, pathologic N0-N1, M0)
* Patients with lymph nodes positive only by cytokeratin staining (i.e., H\&E negative) are eligible
* No squamous cell carcinoma or sarcoma of the breast
* Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy within the past 14 weeks
* Surgical margins at the time of SM must be negative (\> 3 mm) for both invasive carcinoma and for non-invasive ductal carcinoma
* No active local-regional disease
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* ECOG performance status 0-1
* Sex: female
* Menopausal status not specified
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective non-hormonal contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
* No other serious or poorly controlled medical or psychiatric condition that could be exacerbated by, or complicate compliance with study treatment
PRIOR CONCURRENT THERAPY:
* No prior radiation therapy to the breast
* No prior trastuzumab (Herceptin ®)
* No other concurrent chemotherapy
* No concurrent hormonal therapy except the following:
* Steroids given for adrenal failure
* Hormones administered for non-disease-related conditions (e.g., insulin for diabetes, synthroid for hypothyroidism)
* Intermittent dexamethasone as an antiemetic or premedicationReferences
Publications (1)
- RESULTZellars RC, Frassica D, Stearns V, et al.: Phase I/II trial of partial breast irradiation with concurrent dose-dense doxorubicin and cyclophosphamide (ddAC) chemotherapy in early stage breast cancer: report of skin toxicity and cosmetic outcome. [Abstract] Int J Radiat Oncol Biol Phys 69 (3 Suppl): A-44, S26, 2007.