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Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens (PBIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00681993
Recruitment Status : Completed
First Posted : May 21, 2008
Last Update Posted : January 22, 2019
Sponsor:
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Other: Standard Dose Dense Doxorubucin and Cyclophosphamide Other: Standard Doxorubucin and Cyclophosphamide Other: Standard Docetaxel, Carboplatin, and Herceptin Other: Standard Docetaxel, Doxorubucin and Cyclophosphamide Other: Standard Docetaxel and Cyclophosphamide Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "A Feasibility Trial of Partial Breast Irradiation With Various Concurrent Chemotherapy Regimens (PBIC)"
Study Start Date : April 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : March 4, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard ddAC chemotherapy with concurrent radiation therapy
Standard dose-dense Adriamycin and Cyclophosphamide (ddAC) chemotherapy and concurrent radiation therapy (RT)
Other: Standard Dose Dense Doxorubucin and Cyclophosphamide
4 cycles of Standard Dose-Dense Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
Other Names:
  • Doxorubucin (Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS,
  • hydroxydaunorubicin, hydroxydaunomycin)
  • Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)

Active Comparator: Standard AC chemotherapy with concurrent RT
Standard Adriamycin and Cyclophosphamide (AC) chemotherapy and concurrent radiation therapy
Other: Standard Doxorubucin and Cyclophosphamide
4 cycles of Standard Dose Doxorubucin and Cyclophosphamide and concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
Other Names:
  • Doxorubucin (Adriamycin, Rubex, Adriamycin RDF, Adriamycin PFS,
  • hydroxydaunorubicin, hydroxydaunomycin)
  • Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)

Active Comparator: Standard TCarbo H chemotherapy with concurrent RT
Standard Taxotere, Carboplatin and Herceptin (TCarbo H) chemotherapy and concurrent radiation therapy
Other: Standard Docetaxel, Carboplatin, and Herceptin
6 cycles of Standard Docetaxel, Carboplatin and Herceptin chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
Other Names:
  • Docetaxel (Taxotere)
  • Carboplatin (CBDCA, Paraplatin, JM-8)
  • Herceptin (Trastuzumab, RhuMAb HER2, HER2/neu, anti-HER2 humanized
  • monoclonal antibody)

Active Comparator: Standard TAC chemotherapy with concurrent RT
Standard Taxotere, Adriamycin and Cyclophosphamide (TAC) chemotherapy with concurrent radiation therapy
Other: Standard Docetaxel, Doxorubucin and Cyclophosphamide
3 cycles of Standard Docetaxel, Doxorubucin and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
Other Names:
  • Docetaxel (Taxotere)
  • Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)

Active Comparator: Standard TC chemotherapy with concurrent RT
Standard Taxotere and Cyclophosphamide (TC) chemotherapy with concurrent radiation therapy
Other: Standard Docetaxel and Cyclophosphamide
4 cycles of Standard Docetaxel and Cyclophosphamide chemotherapy with concurrent radiation therapy at a dose of 270 cGy per fraction for 15 fractions to a total dose of 40.5 Gy. Treatments will be given Monday through Friday for three weeks. Radiation therapy may start 7 days before, but no later than 7 days after, day 1 of cycle 1 of chemotherapy (C1D1).
Other Names:
  • Docetaxel (Taxotere)
  • Cyclophosphamide (Cytoxan, Neosar, CTX, CPM)




Primary Outcome Measures :
  1. Acute skin toxicities of partial breast irradiation concurrent with chemotherapy (PBIC) [ Time Frame: 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.


  2. Late skin toxicities of PBIC [ Time Frame: 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


  3. Subcutaneous tissue toxicities of PBIC [ Time Frame: 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



Secondary Outcome Measures :
  1. Cosmetic effect of PBIC [ Time Frame: 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).

  2. Local control rate of patients treated with PBIC. [ Time Frame: up to 5 years post-intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

Each of the criteria in the following section must be met in order for a patient to be considered eligible for registration.

  • Patient must be older than 18 years of age
  • Patients must have histologically confirmed (by routine H&E staining) adenocarcinoma of the breast, with the primary tumor < 4 cm and 0 - 3 positive axillary lymph nodes (pathologic T1-2, pathologic N0 -N1, M0). Patients with squamous carcinomas or sarcomas of the breast cancer are NOT eligible.
  • Patient must have a history and physical within six weeks prior to the start of any protocol therapy.
  • Patient must have had a bilateral mammogram prior to surgery.
  • Patients must have undergone a segmental mastectomy (SM) with a level I and ll axillary dissection or sentinel lymph node biopsy. Surgical margins at time of SM must be negative (> or = 2 mm) for both invasive carcinoma and for non-invasive ductal carcinoma. Patients who have post-operative margins which are negative but less than 2mm will be considered eligible if the surgeon states that the margin in question could not be improved.
  • Patient must have a Medical Oncology consult and be recommended to receive one of the following regimens: Cyclophosphamide and Doxorubicin (AC); Taxotere, Doxorubicin and Cyclophosphamide (TAC); Taxotere and Cyclophosphamide (TC) or Taxotere, Carboplatin and Trastuzumab (TCH) prior to registration. The use of additional chemotherapy, hormonal therapy or Trastuzumab after the initial regimen is at the discretion of the medical oncologist.
  • Patients must be registered such that radiation therapy begins no sooner than 7 days prior to, but no later than 7 days after, day 1 of cycle 1 (C1D1). Patient must start chemotherapy and radiation less than 14 weeks from the last breast surgical procedure.
  • Patients must NOT have received any neo adjuvant chemo or hormonal therapy for the current cancer.
  • Patients must have a performance status 0 or 1 by ECOG criteria
  • Patients must not have received prior radiation therapy to the involved breast at any time for any reason.
  • Any patient with active local-regional disease prior to registration is not eligible.
  • No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or any other cancer from which the patient has been disease-free for 5 years.
  • Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing potential must use effective non hormonal contraception while undergoing radiation therapy. Women of child-bearing potential must also have a negative pregnancy test within six weeks prior to start of protocol therapy.
  • Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment.
  • All patients must be informed of the investigational nature of this study and given written informed consent in accordance with institutional and federal guidelines.

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): NCT00681993


Locations
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United States, Maryland
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Breast Cancer Research Foundation
Investigators
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Principal Investigator: Richard Zellars, M.D. The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator: Amit Shah, M.D. York Cancer Center

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT00681993    
Other Study ID Numbers: J0805
IRB00063221 ( Other Identifier: JHM IRB )
First Posted: May 21, 2008    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
cosmetic
effect
breast
irradiation
concurrent
chemotherapy
potential acute
late skin
subcutaneous toxicities
Additional relevant MeSH terms:
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Cyclophosphamide
Carboplatin
Docetaxel
Trastuzumab
Doxorubicin
Liposomal 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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors