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

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ClinicalTrials.gov Identifier: NCT00278109
Recruitment Status : Unknown
Verified March 2014 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2006
Last Update Posted : March 31, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center

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.


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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy
Study Start Date : July 2004
Estimated Primary Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Doxorubicin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental Drug: cyclophosphamide
chemotherapy
Drug: doxorubicin hydrochloride
chemotherapy
Procedure: adjuvant therapy
chemotherapy
Radiation: radiation therapy
chemotherapy



Primary Outcome Measures :
  1. Potential acute, late skin, and subcutaneous toxicity [ Time Frame: 1 year ]
  2. Local control rate [ Time Frame: 1 year ]
  3. Cosmetic effects [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   39 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Cancer Institute (NCI)
Investigators
Study Chair: Richard C. Zellars, MD Sidney Kimmel Comprehensive Cancer Center

Publications of Results:
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 ( U.S. NIH Grant/Contract )
JHOC-J0381
JHOC-04032201
First Posted: January 18, 2006    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: March 2014

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
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors