Partial Breast Irradiation With Chemotherapy
Study Details
Study Description
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 |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: cyclophosphamide
chemotherapy
Other Names:
Drug: Doxorubicin
doxorubicin
Other Names:
Radiation: radiation
radiation
|
Outcome Measures
Primary Outcome Measures
- 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
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | United States | 21231-2410 |
Sponsors and Collaborators
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- National Cancer Institute (NCI)
Investigators
- Study Chair: Richard C. Zellars, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Principal Investigator: Jean Wright, MD, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- J0381
- P30CA006973
- CDR0000446085
- 04-03-22-01
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Two patients did not initiate study procedures: one was found to have residual gross disease during treatment planning, and another withdrew consent. |
| Arm/Group Title | Experimental |
|---|---|
| Arm/Group Description | cyclophosphamide: chemotherapy doxorubicin hydrochloride: chemotherapy adjuvant therapy: chemotherapy radiation therapy: chemotherapy |
| Period Title: Overall Study | |
| STARTED | 25 |
| Completed 3 Cycles of Chemotherapy | 25 |
| COMPLETED | 21 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Experimental |
|---|---|
| Arm/Group Description | cyclophosphamide: chemotherapy doxorubicin hydrochloride: chemotherapy adjuvant therapy: chemotherapy radiation therapy: chemotherapy |
| Overall Participants | 25 |
| Age, Customized (Count of Participants) | |
| Age <= 45 years |
5
20%
|
| Age >= 45 years |
20
80%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
25
100%
|
| Male |
0
0%
|
Outcome Measures
| Title | Number of Participants Experiencing Acute, Late Skin, and Subcutaneous Toxicity |
|---|---|
| Description | 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 |
| Time Frame | up to 5 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data was only collected on participants who completed the study. |
| Arm/Group Title | Experimental |
|---|---|
| Arm/Group Description | cyclophosphamide: chemotherapy doxorubicin hydrochloride: chemotherapy adjuvant therapy: chemotherapy radiation therapy: chemotherapy |
| Measure Participants | 25 |
| Count of Participants [Participants] |
0
0%
|
Adverse Events
| Time Frame | Weekly then monthly then annually for up to 5 years. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Experimental | |
| Arm/Group Description | cyclophosphamide: chemotherapy doxorubicin hydrochloride: chemotherapy adjuvant therapy: chemotherapy radiation therapy: chemotherapy | |
All Cause Mortality |
||
| Experimental | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/25 (0%) | |
Serious Adverse Events |
||
| Experimental | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/25 (4%) | |
| Blood and lymphatic system disorders | ||
| Neutropenia | 1/25 (4%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Experimental | ||
| Affected / at Risk (%) | # Events | |
| Total | 21/25 (84%) | |
| Blood and lymphatic system disorders | ||
| Absolute neutrophil count | 4/25 (16%) | 4 |
| Gastrointestinal disorders | ||
| Nausea & vomiting | 3/25 (12%) | 3 |
| General disorders | ||
| Fatigue | 1/25 (4%) | 1 |
| Immune system disorders | ||
| Mucositis | 2/25 (8%) | 2 |
| Infections and infestations | ||
| Contralateral breast abscess | 1/25 (4%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||
| cough/bronchospasms | 1/25 (4%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| perianal dermatitis | 1/25 (4%) | 1 |
| foot blisters | 1/25 (4%) | 1 |
| Grade 1 Radiation Dermatitis | 21/25 (84%) | 21 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Richard Zellars MD |
|---|---|
| Organization | Indiana University School of Medicine |
| Phone | 3179444505 |
| rzellars@iu.edu |
- J0381
- P30CA006973
- CDR0000446085
- 04-03-22-01