Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Standard Dose Dense Doxorubucin and Cyclophosphamide; Other: Standard Docetaxel, Doxorubucin and Cyclophosphamide; Other: Standard Doxorubucin and Cyclophosphamide; Other: Standard Docetaxel and Cyclophosphamide; Other: Standard Docetaxel, Carboplatin, and Herceptin

• Registration Number: NCT00681993
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

Breast conserving therapy, (BCT), which consists of wide local excision of the tumor followed by 6 weeks of whole breast irradiation, (WBI), is integral to the management of breast cancer. Evidence now suggests that WBI may not be necessary and treatment to the involved area only, partial breast irradiation, (PBI), may suffice. PBI can be achieved by interstitial or intracavitary brachytherapy, intra-op, or post op external beam radiation therapy. The feasibility, toxicity and efficacy of PBI are currently being studied in both the U.S. and Europe. Review of smaller studies suggests that PBI will prove to be comparable to WBI. Chemotherapy combined with radiation has been shown to increase local control in BCT when compared to radiation alone. However there is little data on how sequencing or timing of these therapies with respect to one another affect outcome. As a result there is no consensus about the optimal combination. There are real and potential benefits to concurrent chemo-radiation therapy. Concurrent therapy 1) allows both treatments to start closer to surgery, theoretically maximizing the benefits of each modality; 2) shortens the overall treatment program; and 3) may also improve local control via chemo-sensitization of residual cancer cells. However, concurrent chemotherapy and WBI have been associated with prohibitive skin toxicity. Since less breast tissue is treated with PBI, this skin toxicity may no longer be prohibitive. We have shown in J0381 that PBI and concurrent dose dense AC is safe. As a follow-up, we propose a phase I/II trial addressing the toxicity and efficacy associated with PBI delivered concurrently with various chemotherapy regimens.

Detailed Description

1. Partial Breast Irradiation with concurrent chemotherapy (various regimens. Subjects will receive Segmental Mastectomy (Lumpectomy)

2. Medical Oncology Evaluation

3. Consent/Registration Pre-RT evaluation

4. Simulation/Treatment Planning

5. Chemo-Radiation Therapy:

ddAC, Std AC, TAC, TC, TCH or TH Concurrent with PBI - (270 cGy per fraction for 15 fractions). RT may start up to 7days prior to C1D1, but no later than 7 days after C1D1 (+/- 7 days of C1D1 radiation may start)

6. Further chemotherapy, hormonal therapy or biologic therapy at the medical oncologist's discretion

7. F/U Schedule

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-19
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-21
• Primary Completion: 2012-06
• Study Completion: 2016-03-04
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard ddAC chemotherapy with concurrent radiation therapy	Standard Dose Dense Doxorubucin and Cyclophosphamide	Standard dose-dense Adriamycin and Cyclophosphamide (ddAC) chemotherapy and concurrent radiation therapy (RT)
Standard TAC chemotherapy with concurrent RT	Standard Docetaxel, Doxorubucin and Cyclophosphamide	Standard Taxotere, Adriamycin and Cyclophosphamide (TAC) chemotherapy with concurrent radiation therapy
Standard AC chemotherapy with concurrent RT	Standard Doxorubucin and Cyclophosphamide	Standard Adriamycin and Cyclophosphamide (AC) chemotherapy and concurrent radiation therapy
Standard TC chemotherapy with concurrent RT	Standard Docetaxel and Cyclophosphamide	Standard Taxotere and Cyclophosphamide (TC) chemotherapy with concurrent radiation therapy
Standard TCarbo H chemotherapy with concurrent RT	Standard Docetaxel, Carboplatin, and Herceptin	Standard Taxotere, Carboplatin and Herceptin (TCarbo H) chemotherapy and concurrent radiation therapy

Primary Outcome Measures

Name	Time	Method
Subcutaneous tissue toxicities of PBIC	up to 5 years post-intervention	Subcutaneous tissue toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe 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
Late skin toxicities of PBIC	up to 5 years post-intervention	Late Skin toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity: 0= none; 1= slight atrophy, pigmentation change, some hair loss; 2= patchy atrophy, moderate telangiectasias, total hair loss; 3= marked atrophy, gross telangiectasias; 4= ulceration
Acute skin toxicities of partial breast irradiation concurrent with chemotherapy (PBIC)	up to 5 years post-intervention	Acute Skin toxicity will be scored on a scale ranging from 0-4, where a higher score reflects more severe toxicity: 0= no change; 1= follicular, fain 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, pitting edema; 4= ulceration, hemorrhage, necrosis.

Secondary Outcome Measures

Name	Time	Method
Cosmetic effect of PBIC	up to 5 years post-intervention	Number of participants with Poor, Fair, Good, or Excellent cosmetic effect after PBIC. Cosmetic effect will be graded by the investigator and participant as specified by the grading criteria in the Study Protocol (grading criteria description too large for this field).
Local control rate of patients treated with PBIC.	up to 5 years post-intervention

Trial Locations

Locations (1)

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States