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Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer

Primary Purpose

Cardiac Toxicity, Inflammatory Breast Cancer, Stage IIIA Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
dexrazoxane hydrochloride
doxorubicin hydrochloride
cyclophosphamide
paclitaxel
trastuzumab
therapeutic conventional surgery
radiation therapy
tamoxifen citrate
laboratory biomarker analysis
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Toxicity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Histologically confirmed primary infiltrating adenocarcinoma of the breast Confirmed by core needle biopsy or incisional biopsy Amplification of HER-2 by FISH Overexpression (3+) of HER-2 by immunohistochemistry Staging criteria after complete clinical and radiographic staging: T3, N1, M0 Any T, N2 or N3, M0 T4, any N, M0, including clinical or pathological inflammatory disease Regional stage IV disease with supraclavicular or infraclavicular lymph nodes as only site of metastasis Measurable or evaluable disease Prior ductal carcinoma in situ of the ipsilateral breast allowed if treated with excision only without mastectomy or radiation Metaplastic carcinoma allowed Synchronous bilateral primary disease allowed (provided at least 1 cancer meets staging criteria) No dermal lymphatic involvement with clinical inflammatory changes Hormone receptor status: Estrogen receptor positive or negative Progesterone receptor positive or negative Female Granulocyte count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2 times ULN Creatinine no greater than 1.5 times ULN LVEF normal by MUGA No uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension) No other currently active malignancy except nonmelanoma skin cancer Not pregnant or nursing Fertile patients must use effective contraception Patients taking tamoxifen must use effective nonhormonal contraception during and for 2 months after study No prior chemotherapy No other concurrent chemotherapy No more than 4 weeks of prior tamoxifen for disease Prior tamoxifen or raloxifene for longer than 4 weeks as chemoprevention allowed No concurrent tamoxifen or raloxifene No other concurrent hormonal therapy except for steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic See Disease Characteristics No prior radiotherapy for index malignancy No prior radiotherapy to the ipsilateral breast, regional nodes, mediastinum, or heart Prior radiotherapy to the contralateral breast for ductal carcinoma in situ or early stage invasive breast cancer allowed provided earlier radiotherapy does not preclude optimal delivery of study radiotherapy and criterion of low risk for metastasis from first malignancy is met See Disease Characteristics No prior sentinel lymph node biopsy

Sites / Locations

  • Cancer and Leukemia Group B

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm I (chemoprotection, monoclonal antibody, radiotherapy)

Arm II (chemoprotection, radiotherapy, surgery, trastuzumab)

Arm III (chemoprotection, monoclonal antibody, radiotherapy)

Arm IV (chemoprotection, paclitaxel, surgery, radiotherapy)

Arm V (combination chemo, radiotherapy, long term trastuzumab)

Arm VI (combination chemo, paclitaxel, surgery, radiotherapy)

Arm VII (combination chemo, monoclonal antibody, radiotherapy)

Arm VIII (combination chemotherapy, paclitaxel, radiotherapy)

Arm Description

Patients receive dexrazoxane IV over 10-20 minutes, doxorubicin IV over 5-10 minutes, and cyclophosphamide IV over 30 minutes on days 1, 22, 43, and 64. Patients receive paclitaxel IV over 1 hour and trastuzumab (Herceptin) IV over 30-90 minutes on days 85, 92, 99, 106, 113, 120, 127, 134, 141, 148, 155, and 162. Approximately 1-2 weeks after completion of neoadjuvant chemotherapy, patients undergo breast conservation surgery, modified radical mastectomy, or mastectomy. Patients with unacceptable toxicity or locoregional disease progression may undergo surgery prior to week 24 (i.e., completion of neoadjuvant chemotherapy). Beginning 2-4 weeks after breast conservation surgery or 3-5 weeks after mastectomy, patients undergo radiotherapy daily 5 days a week for 6-8 weeks. Patients receive long-term trastuzumab IV over 30-90 minutes weekly for 40 weeks beginning on week 36 (day 254).

Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel (without trastuzumab) as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I.

Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation only for 40 weeks after completion of radiotherapy.

Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III.

Patients receive doxorubicin and cyclophosphamide (without dexrazoxane) as in arm I. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I.

Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I.

Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III.

Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III.

Outcomes

Primary Outcome Measures

Median number of positive axillary lymph nodes
Compared in the Herceptin and no Herceptin groups and in the dexrazoxane versus no dexrazoxane groups using a chi-square test and a two-sample t test, respectively.
Pathologic complete response (CR) rate in the breast and axilla
Compared in the Herceptin and no Herceptin groups and in the dexrazoxane versus no dexrazoxane groups using a chi-square test and a two-sample t test, respectively.
Cardiac toxicity, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Assessment will use exact binomial comparison of two proportions.
Cardiac toxicity, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Assessment will use exact binomial comparison of two proportions.
Disease-free survival
Proportional hazards regression models will be used.

Secondary Outcome Measures

Occurrence of grade 3 or higher late cardiac or neurological toxicity, or secondary acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS)
Clinical/radiographic response in the breast and axilla after doxorubicin hydrochloride and cyclophosphamide with or without dexrazoxane hydrochloride
Clinical/radiographic response in the breast and axilla after paclitaxel with or without trastuzumab
Time to local/regional recurrence
Time to completion of treatment through radiotherapy
Rate of breast conservation for patients considered "candidates" prior to treatment
Overall survival
Proportional hazards regression models will be used.

Full Information

First Posted
May 6, 2001
Last Updated
January 15, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00016276
Brief Title
Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
Official Title
A 2X2X2 Factorial Randomized Phase III Trial Of Multimodality Therapy Comparing 4 Cycles Of Doxorubicin And Cyclophosphamide With Or Without Dexrazoxane (AC+/-Z) Followed By 12 Weeks Of Weekly Paclitaxel With Or Without Trastuzumab (T+/-H) Followed By Local Therapy Followed By 40 Weeks Of Weekly Trastuzumab Or None In Women With HER-2+ STAGE IIIA, IIIB OR REGIONAL STAGE IV BREAST CANCER
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Terminated
Why Stopped
Administratively complete.
Study Start Date
May 2001 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
Randomized phase III trial to compare the effectiveness of combination chemotherapy, surgery, and radiation therapy with or without dexrazoxane and trastuzumab in treating women who have stage IIIA, stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy combined with surgery and radiation therapy is more effective with or without dexrazoxane and trastuzumab in treating breast cancer
Detailed Description
OBJECTIVES: I. Determine the time to locoregional recurrence, time to completion of treatment, and overall survival in women with HER-2+ stage IIIA or IIIB or regional stage IV breast cancer treated with doxorubicin and cyclophosphamide with or without dexrazoxane, followed by paclitaxel with or without trastuzumab (Herceptin), followed by surgery and radiotherapy with or without trastuzumab. II. Determine whether addition of trastuzumab to paclitaxel therapy improves response at 24 weeks of therapy in these patients. III. Determine whether addition of trastuzumab to paclitaxel therapy increases the rate of cardiotoxicity in these patients. IV. Determine whether addition of dexrazoxane to doxorubicin and cyclophosphamide compromises response in these patients. V. Determine whether addition of dexrazoxane to doxorubicin and cyclophosphamide reduces the rate of cardiotoxicity in these patients. VI. Determine whether long-term trastuzumab after local therapy improves disease-free survival in these patients. VII. Determine whether long-term trastuzumab after local therapy increases the rate of cardiotoxicity in these patients. VIII. Determine the occurrence of any grade 3 or higher toxicity, second malignancies, acute myelogenous leukemia, or myelodysplastic syndrome in patients treated with these regimens. IX. Determine the eventual rate of breast conservation in those patients considered candidates for breast conservation prior to neoadjuvant treatment. X. Determine the clinical response after doxorubicin and cyclophosphamide with or without dexrazoxane and the clinical/mammographic/ultrasound response after paclitaxel with or without trastuzumab, compared to the pathologic response at definitive surgery in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to stage (inflammatory vs noninflammatory inoperable stage III/ regional stage IV vs operable stage III). Patients are randomized to 1 of 8 treatment arms. Arm I: Patients receive dexrazoxane IV over 10-20 minutes, doxorubicin IV over 5-10 minutes, and cyclophosphamide IV over 30 minutes on days 1, 22, 43, and 64. Patients receive paclitaxel IV over 1 hour and trastuzumab (Herceptin) IV over 30-90 minutes on days 85, 92, 99, 106, 113, 120, 127, 134, 141, 148, 155, and 162. Approximately 1-2 weeks after completion of neoadjuvant chemotherapy, patients undergo breast conservation surgery, modified radical mastectomy, or mastectomy. Patients with unacceptable toxicity or locoregional disease progression may undergo surgery prior to week 24 (i.e., completion of neoadjuvant chemotherapy). Beginning 2-4 weeks after breast conservation surgery or 3-5 weeks after mastectomy, patients undergo radiotherapy daily 5 days a week for 6-8 weeks. Patients receive long-term trastuzumab IV over 30-90 minutes weekly for 40 weeks beginning on week 36 (day 254). Arm II: Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel (without trastuzumab) as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I. Arm III: Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation only for 40 weeks after completion of radiotherapy. Arm IV: Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III. Arm V: Patients receive doxorubicin and cyclophosphamide (without dexrazoxane) as in arm I. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I. Arm VI: Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I. Arm VII: Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III. Arm VIII: Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III. Treatment continues in all arms in the absence of distant disease progression. Beginning within 12 weeks of completion of neoadjuvant chemotherapy, hormone receptor-positive patients may receive oral tamoxifen daily for 5 years. Patients are followed every 6 months for 5 years and then annually for 5 years. PROJECTED ACCRUAL: A total of 396 patients will be accrued for this study within 4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Toxicity, Inflammatory Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
396 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (chemoprotection, monoclonal antibody, radiotherapy)
Arm Type
Experimental
Arm Description
Patients receive dexrazoxane IV over 10-20 minutes, doxorubicin IV over 5-10 minutes, and cyclophosphamide IV over 30 minutes on days 1, 22, 43, and 64. Patients receive paclitaxel IV over 1 hour and trastuzumab (Herceptin) IV over 30-90 minutes on days 85, 92, 99, 106, 113, 120, 127, 134, 141, 148, 155, and 162. Approximately 1-2 weeks after completion of neoadjuvant chemotherapy, patients undergo breast conservation surgery, modified radical mastectomy, or mastectomy. Patients with unacceptable toxicity or locoregional disease progression may undergo surgery prior to week 24 (i.e., completion of neoadjuvant chemotherapy). Beginning 2-4 weeks after breast conservation surgery or 3-5 weeks after mastectomy, patients undergo radiotherapy daily 5 days a week for 6-8 weeks. Patients receive long-term trastuzumab IV over 30-90 minutes weekly for 40 weeks beginning on week 36 (day 254).
Arm Title
Arm II (chemoprotection, radiotherapy, surgery, trastuzumab)
Arm Type
Experimental
Arm Description
Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel (without trastuzumab) as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I.
Arm Title
Arm III (chemoprotection, monoclonal antibody, radiotherapy)
Arm Type
Experimental
Arm Description
Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation only for 40 weeks after completion of radiotherapy.
Arm Title
Arm IV (chemoprotection, paclitaxel, surgery, radiotherapy)
Arm Type
Experimental
Arm Description
Patients receive dexrazoxane, doxorubicin, and cyclophosphamide as in arm I. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III.
Arm Title
Arm V (combination chemo, radiotherapy, long term trastuzumab)
Arm Type
Experimental
Arm Description
Patients receive doxorubicin and cyclophosphamide (without dexrazoxane) as in arm I. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I.
Arm Title
Arm VI (combination chemo, paclitaxel, surgery, radiotherapy)
Arm Type
Experimental
Arm Description
Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients receive long-term trastuzumab as in arm I.
Arm Title
Arm VII (combination chemo, monoclonal antibody, radiotherapy)
Arm Type
Experimental
Arm Description
Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel and trastuzumab as in arm I. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III.
Arm Title
Arm VIII (combination chemotherapy, paclitaxel, radiotherapy)
Arm Type
Experimental
Arm Description
Patients receive doxorubicin and cyclophosphamide as in arm V. Patients receive paclitaxel as in arm II. Patients undergo surgery and radiotherapy as in arm I. Patients undergo observation as in arm III.
Intervention Type
Drug
Intervention Name(s)
dexrazoxane hydrochloride
Other Intervention Name(s)
Cardioxane, Savene, Totect, Zinecard
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Other Intervention Name(s)
ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
CPM, CTX, Cytoxan, Endoxan, Endoxana
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, TAX, Taxol
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
trastuzumab
Other Intervention Name(s)
anti-c-erB-2, Herceptin, MOAB HER2
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Undergo breast conservation surgery, modified radical mastectomy, or mastectomy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Other Intervention Name(s)
irradiation, radiotherapy, therapy, radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Drug
Intervention Name(s)
tamoxifen citrate
Other Intervention Name(s)
Nolvadex, TAM, tamoxifen, TMX
Intervention Description
Given orally
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Median number of positive axillary lymph nodes
Description
Compared in the Herceptin and no Herceptin groups and in the dexrazoxane versus no dexrazoxane groups using a chi-square test and a two-sample t test, respectively.
Time Frame
At 24 weeks
Title
Pathologic complete response (CR) rate in the breast and axilla
Description
Compared in the Herceptin and no Herceptin groups and in the dexrazoxane versus no dexrazoxane groups using a chi-square test and a two-sample t test, respectively.
Time Frame
At 24 weeks
Title
Cardiac toxicity, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Description
Assessment will use exact binomial comparison of two proportions.
Time Frame
At 24 weeks
Title
Cardiac toxicity, graded according to the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Description
Assessment will use exact binomial comparison of two proportions.
Time Frame
At 78 weeks
Title
Disease-free survival
Description
Proportional hazards regression models will be used.
Time Frame
Date of study entry to date of first relapse (local or distant) or death due to any cause, assessed up to 10 years
Secondary Outcome Measure Information:
Title
Occurrence of grade 3 or higher late cardiac or neurological toxicity, or secondary acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS)
Time Frame
Up to 10 years
Title
Clinical/radiographic response in the breast and axilla after doxorubicin hydrochloride and cyclophosphamide with or without dexrazoxane hydrochloride
Time Frame
At 12 weeks
Title
Clinical/radiographic response in the breast and axilla after paclitaxel with or without trastuzumab
Time Frame
At 24 weeks
Title
Time to local/regional recurrence
Time Frame
Up to 10 years
Title
Time to completion of treatment through radiotherapy
Time Frame
Up to 5 years
Title
Rate of breast conservation for patients considered "candidates" prior to treatment
Time Frame
Up to 10 years
Title
Overall survival
Description
Proportional hazards regression models will be used.
Time Frame
Date of study entry to date of due to any cause, assessed up to 10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically confirmed primary infiltrating adenocarcinoma of the breast Confirmed by core needle biopsy or incisional biopsy Amplification of HER-2 by FISH Overexpression (3+) of HER-2 by immunohistochemistry Staging criteria after complete clinical and radiographic staging: T3, N1, M0 Any T, N2 or N3, M0 T4, any N, M0, including clinical or pathological inflammatory disease Regional stage IV disease with supraclavicular or infraclavicular lymph nodes as only site of metastasis Measurable or evaluable disease Prior ductal carcinoma in situ of the ipsilateral breast allowed if treated with excision only without mastectomy or radiation Metaplastic carcinoma allowed Synchronous bilateral primary disease allowed (provided at least 1 cancer meets staging criteria) No dermal lymphatic involvement with clinical inflammatory changes Hormone receptor status: Estrogen receptor positive or negative Progesterone receptor positive or negative Female Granulocyte count at least 1,000/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than upper limit of normal (ULN) AST no greater than 2 times ULN Creatinine no greater than 1.5 times ULN LVEF normal by MUGA No uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension) No other currently active malignancy except nonmelanoma skin cancer Not pregnant or nursing Fertile patients must use effective contraception Patients taking tamoxifen must use effective nonhormonal contraception during and for 2 months after study No prior chemotherapy No other concurrent chemotherapy No more than 4 weeks of prior tamoxifen for disease Prior tamoxifen or raloxifene for longer than 4 weeks as chemoprevention allowed No concurrent tamoxifen or raloxifene No other concurrent hormonal therapy except for steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic See Disease Characteristics No prior radiotherapy for index malignancy No prior radiotherapy to the ipsilateral breast, regional nodes, mediastinum, or heart Prior radiotherapy to the contralateral breast for ductal carcinoma in situ or early stage invasive breast cancer allowed provided earlier radiotherapy does not preclude optimal delivery of study radiotherapy and criterion of low risk for metastasis from first malignancy is met See Disease Characteristics No prior sentinel lymph node biopsy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Graham
Organizational Affiliation
Cancer and Leukemia Group B
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer and Leukemia Group B
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60606
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer

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