Clinical trial · Interventional
Paclitaxel Plus Radiation Therapy in Treating Women With Stage II or Stage III Breast Cancer
Concurrent Taxol (Paclitaxel) and Definitive Breast Radiation Therapy in Early Stage Breast Cancer Following Four Cycles of Adriamycin/Cytoxan Chemotherapy
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining paclitaxel with radiation therapy may kill more tumor cells. PURPOSE: This trial is to study the effectiveness of concurrent administration of chemotherapy and radiation therapy in treating women who have stage II or stage III breast cancer by examining the complications and cosmetic effects.
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 |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Determine the feasibility of concurrent paclitaxel and breast radiotherapy
- timeFrame
- Followed every 3 months for 1 year
- description
- Ability to deliver appropriate doses of radiation therapy within the appropriate time course
- measure
- chemotherapy dose achieved during concurrent Taxol and radiation therapy.
- timeFrame
- Followed every 3 months for 1 year
Secondary outcomes (3)
- measure
- Cosmetic outcome based upon established descriptive parameters: excellent, good, fair, and poor.
- timeFrame
- 1 year
- description
- These parameters will be assessed by medical and radiation oncology. We expect at least a \> 60% completion rate with this treatment, which translates into confidence limits of 46% to 74% when 40 patients are investigated.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Stage II or III invasive breast cancer * Prior breast conserving surgery (lumpectomy or quadrantectomy) with ipsilateral axillary lymph node dissection required * No prior contralateral breast cancer * No metastatic disease * Prior ductal carcinoma in situ or lobular carcinoma in situ of the breast allowed unless treated with radiation or chemotherapy * Doxorubicin and cyclophosphamide adjuvant chemotherapy completed within past 3 weeks * Candidate for definitive radiotherapy * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm3 * Granulocyte count at least 2,000/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT/AST no greater than 1.5 times ULN Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No concurrent poorly controlled ischemic heart disease or congestive heart failure * LVEF at least 45% by MUGA scan or echocardiogram Pulmonary: * No concurrent severe chronic obstructive or restrictive pulmonary disease Other: * Not pregnant or nursing * Fertile patients must use effective contraception * No concurrent severe medical or psychiatric illness * No concurrent severe diabetes mellitus * No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix treated with local excision PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent filgrastim (G-CSF) Chemotherapy: * See Disease Characteristics * Prior tamoxifen allowed * No concurrent tamoxifen Endocrine therapy: * Not specified Radiotherapy: * No prior radiation to the breast Surgery: * Recovered form prior surgery Other: * No concurrent adjuvant therapy on another clinical trial
References
Publications (0)
Data not yet available