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Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer

This study has been terminated.
(Study was discontinued due to lack of accrual.)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00603408
First received: December 28, 2007
Last updated: July 8, 2016
Last verified: July 2016
  Purpose
The purpose of this study is to determine whether Cisplatin when given with radiation therapy prior to surgery is effective in improving response to treatment in breast cancer patients. Tumor, blood and bone marrow samples will be collected in this study and will also help researchers determine if cisplatin is able to change tumor DNA so it cannot multiply itself and create more tumor cells, and cause the tumor cells to die.

Condition Intervention Phase
Breast Cancer
Drug: Cisplatin
Radiation: Radiation Therapy
Procedure: Mastectomy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Neoadjuvant Cisplatin Based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer: Clinical Outcome and Correlation to Biological Parameters

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Overall Response [ Time Frame: At the time of surgery (week 13) ] [ Designated as safety issue: No ]
    • Complete response: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level
    • Partial response: at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD
    • Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started,
    • Progressive disease: at least a 20% increase in the sum of the LD of the target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions, appearance of one more new lesions, or unequivocal progression of existing non-target lesions.


Secondary Outcome Measures:
  • Time to Disease Progression [ Time Frame: Until study was terminated (23.5 months) ] [ Designated as safety issue: No ]
    Time to disease progression: time from registration until objective tumor progression; does not include deaths

  • Overall Survival Rate (OS) [ Time Frame: Until study was terminated (23.5 months) ] [ Designated as safety issue: No ]
    OS = Time from registration until death from any cause

  • Number of Participants With Surgical Complications [ Time Frame: 30 days post surgery (week 17-18) ] [ Designated as safety issue: Yes ]
  • Number of Participants With Medical Toxicities [ Time Frame: 30 days post surgery (week 17-18) ] [ Designated as safety issue: Yes ]
    The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting. All detailed information regarding serious and other adverse events are listed in the Adverse Event module of these results.

  • Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Develop Animal Models of Triple Negative Breast Cancers [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Provide Samples for the Development of the FNA Assay [ Time Frame: At time of IVAD placement and at time of surgery ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: December 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cisplatin + Radiation + Recommended Surgery

Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10

Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.

Surgery (recommended) mastectomy with/without axillary lymph node dissection

Drug: Cisplatin
Other Name: cisplatinum
Radiation: Radiation Therapy Procedure: Mastectomy
(RECOMMENDED BUT NOT REQUIRED)

Detailed Description:

After Diagnosis: Clinical Stage IIB, III Breast Cancer, Triple Negative

Week 0: Port-A-Cath placement Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration Sentinel Lymph node biopsy, if axillary US negative

Week 1: Chemo & Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m^2 (cycle 1) Days 2-5: Radiation Therapy

Week 2: Radiation Day 1-5: Radiation Therapy

Week 3: Radiation Days 1-5: Radiation Therapy

Week 4: Chemo & Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m^2 (cycle 2) Days 2-5: Radiation Therapy

Week 5: Radiation Days 1-5: Radiation Therapy

Week 6: Radiation Days 1-5: Radiation Therapy

Week 7: Chemo Day 1: Cisplatin 75mg/m^2 (cycle 3)

Week 10: Chemo Day 1:Cisplatin 75mg/m^2 (cycle 4)

Week 13: Surgery Mastectomy with/without axillary lymph node dissection Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration

Week 15 - 21: Recommended (physician discretion) Adjuvant Chemo Dose dense Doxorubicin: 60mg/m^2 & Cyclophosphamide: 600mg/m^2, every 2 weeks for 4 cycles

Week 21 - 29: Recommended (physician discretion) Adjuvant Chemo Paclitaxel: 175mg/m^2 every 2 weeks for 4 cycles

Week 52 IVAD Removal, Bone marrow aspiration

Follow-Up (up to 5 years) Q 3 months for year 1 Q 6 months for year 2-3 Q 1 year for years 4-5

  Eligibility

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

Inclusion Criteria:

  • Patients must be >= 18 years of age
  • Patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.
  • Tumor classified as clinically stage T2, T3 or T4 with any N (NX, N1, N2, or N3).
  • Tumor does not express the following biomarkers: estrogen receptor, progesterone receptor, Her2/neu
  • Adequate organ function defined as:

    • Serum Creatinine <= 1.5 x upper limit of institutional normal.
    • ALT, AST, ALK Phos <= 1.5 x upper limit of institutional normal.
    • Bilirubin <= 1.5 x upper limit of institutional normal.
    • Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.

Exclusion Criteria:

  • No evidence of distant metastasis present by CT, Bone scan, or physical exam. If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions should be further clarified by additional testing such as PET or MRI.
  • No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival.
  • Women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
  • Karnofsky Performance Status of <= 70.
  • Patients with known history neural deficiencies (e.g. peripheral neuropathy).
  • Patients with a known hearing impairment (hearing loss or severe tinnitus).
  • Male patients
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603408

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Rebecca Aft, MD, PhD Washington University School of Medicine
  More Information

Additional Information:
Publications:
Garber, J., Richardson, A., Harris, L., Miron, A., Silver, D., Golshan, M., Ryan, P., Ganesan, S., Wang, Z., Clarke, K., Inglehart, J., and Winer, E. Neoadjuvant cisplatin in triple negative breast cancer. SABCS, 2006.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00603408     History of Changes
Other Study ID Numbers: 07-0913 
Study First Received: December 28, 2007
Results First Received: July 8, 2016
Last Updated: July 8, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Breast Cancer
Locally Advanced
Neoadjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 30, 2016