Partial Breast Irradiation With Chemotherapy

NCT00278109 | Completed Phase 1 Results

• 4 other identifiers: J0381P30CA006973CDR000044608504-03-22-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity

  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

  up to 5 years

Study Arms (1)

PBI with Concurrent Chemotherapy

EXPERIMENTAL

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.

Drug: cyclophosphamide; Drug: Doxorubicin; Radiation: radiation

Interventions

cyclophosphamide DRUG

chemotherapy

Also known as: adriamycin

PBI with Concurrent Chemotherapy

Doxorubicin DRUG

doxorubicin

Also known as: cytoxan

PBI with Concurrent Chemotherapy

radiation RADIATION

radiation

PBI with Concurrent Chemotherapy

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 premedication

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Doxorubicin; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Physical Phenomena

Results Point of Contact

• Title: Richard Zellars MD
• Organization: Indiana University School of Medicine

rzellars@iu.edu

3179444505

Study Officials

• Richard C. Zellars, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

• Jean Wright, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2006
• First Posted: January 18, 2006
• Study Start: July 1, 2004
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 19, 2020
• Results First Posted: March 28, 2019

Record last verified: 2019-03

Locations

US (1)