Partial Breast Irradiation With Chemotherapy

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: cyclophosphamide; Drug: Doxorubicin; Radiation: radiation

• Registration Number: NCT00278109
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

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.

Detailed Description

OBJECTIVES:

* Assess the potential acute and late skin and subcutaneous toxicities in women with resected stage I or II breast cancer treated with partial breast irradiation (PBI) and concurrent cyclophosphamide/doxorubicin (AC) chemotherapy.

* Assess the cosmetic effects of partial breast irradiation/chemotherapy (PBIC) in these patients.

* Assess the local control rate in patients treated with this regimen.

OUTLINE: Patients undergo partial breast radiotherapy once daily, 5 days a week, for 3 weeks. Patients also receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment with doxorubicin and cyclophosphamide repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for approximately 10 years.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2006-01-16
• Study First Submitted QC: 2006-01-16
• Study First Posted: 2006-01-18
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Results First Submitted: 2019-02-13
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-05
• Results First Posted: 2019-03-28
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PBI with Concurrent Chemotherapy	radiation	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.
PBI with Concurrent Chemotherapy	cyclophosphamide	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.
PBI with Concurrent Chemotherapy	Doxorubicin	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity	up to 5 years	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

Trial Locations

Locations (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States