Partial Breast Irradiation With Chemotherapy

NCT ID: NCT00278109

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2016-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PBI with Concurrent Chemotherapy

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.

Group Type: EXPERIMENTAL

cyclophosphamide

Intervention Type: DRUG

chemotherapy

Doxorubicin

Intervention Type: DRUG

doxorubicin

radiation

Intervention Type: RADIATION

radiation

Interventions

cyclophosphamide

chemotherapy

Intervention Type: DRUG

Doxorubicin

doxorubicin

Intervention Type: DRUG

radiation

radiation

Intervention Type: RADIATION

Other Intervention Names

adriamycin; cytoxan

Eligibility Criteria

Inclusion Criteria

• 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 premedication

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard C. Zellars, MD

Role: STUDY_CHAIR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Jean Wright, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

References

Zellars 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.

Reference Type: RESULT

Other Identifiers

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CDR0000446085

Identifier Type: -

Identifier Source: secondary_id

04-03-22-01

Identifier Type: OTHER

Identifier Source: secondary_id

J0381

Identifier Type: -

Identifier Source: org_study_id