Radiation Therapy, Cyclophosphamide, and Doxorubicin in Treating Women With Stage I or Stage II Breast Cancer Who Have Undergone Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00278109
First received: January 16, 2006
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Potential acute, late skin, and subcutaneous toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Local control rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cosmetic effects [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 42
Study Start Date: July 2004
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental Drug: cyclophosphamide
chemotherapy
Drug: doxorubicin hydrochloride
chemotherapy
Procedure: adjuvant therapy
chemotherapy
Radiation: radiation therapy
chemotherapy

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.

  Eligibility

Ages Eligible for Study:   39 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00278109

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Richard C. Zellars, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
Publications:
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.

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00278109     History of Changes
Other Study ID Numbers: J0381 CDR0000446085, P30CA006973, JHOC-J0381, JHOC-04032201
Study First Received: January 16, 2006
Last Updated: March 28, 2014
Health Authority: United States: Federal Government

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014