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Neoadjuvant Platinum-based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01167192
First received: July 14, 2010
Last updated: September 8, 2016
Last verified: September 2016
  Purpose
The purpose of this study is to determine whether platinum-based chemotherapy (either cisplatin or carboplatin), when given with radiation therapy prior to surgery, is effective in improving response to treatment in triple negative breast cancer patients. This treatment is being studied in this type of breast cancer because it does not respond well to commonly used treatments such as tamoxifen or herceptin.

Condition Intervention Phase
Breast Neoplasms
Drug: Cisplatin
Drug: Carboplatin
Radiation: Radiation therapy
Procedure: Mastectomy (recommended but not mandatory)
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 Platinum-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:
  • Response Rate as Measured by Number of Participants Who Achieved Complete Response (CR) or Partial Response (PR) [ Time Frame: Prior to surgery (approximately 12-16 weeks from registration) ] [ Designated as safety issue: No ]
    • Complete response (CR) = disappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor marker level.
    • Partial response (PR) = at least a 30% decrease in the sum of the longest diameter (LD) of the target lesions taking as reference the baseline sum LD

  • Relationship Between Tumor Response and Deficiencies in DNA Repair Mechanisms [ Time Frame: Prior to surgery (approximately 12-16 weeks from registration) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the Effect of Neoadjuvant Chemoradiation on Tumor Response to Therapy [ Time Frame: Prior to surgery (approximately 12-16 weeks from registration) ] [ Designated as safety issue: No ]
  • Time to Disease Progression [ Time Frame: Up to 5 years from registration ] [ Designated as safety issue: No ]
    Progression = at least a 20% increase in the sum of the longest diameter of the target lesions taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, appearance of one or more new lesions, unequivocal progression of existing non-target lesions.

  • Number of Participants With Surgical Complications [ Time Frame: 30 days post surgery (approximately 16-20 weeks from registration) ] [ Designated as safety issue: No ]
  • Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow [ Time Frame: Up to 15 months from registration ] [ Designated as safety issue: No ]
  • Overall Survival Rate [ Time Frame: Median follow-up was 59.9 months ] [ Designated as safety issue: No ]
  • Medical Toxicities as Measured by Number of Grade 3 or Higher Adverse Events [ Time Frame: 30 days post surgery (approximately 16-20 weeks after start of registration) ] [ Designated as safety issue: Yes ]
  • Successful Development of Animal Models of Triple Negative Breast Cancers as Measured by the Ability to Grow the Tumors in Mice. [ Time Frame: At the time of IVAD placement and at the time of surgery ] [ Designated as safety issue: No ]
  • Successful Development of Animal Models for Triple Negative Breast Cancers as Measured by the Ability to Passage the Tumors in Mice [ Time Frame: At the time of IVAD placement and at the time of surgery ] [ Designated as safety issue: No ]
  • Successful Development of Animal Models in Triple Negative Breast Cancers as Measured by the Ability of the Tumors to Metastasize to Other Organs [ Time Frame: At the time of IVAD placement and at the time of surgery ] [ Designated as safety issue: No ]
  • Successful Development of Animal Models of Triple Negative Breast Cancer as Measured by the Genetic Similarity Between the Primary Tumor and the Tumor in Animals [ Time Frame: At the time of IVAD placement and at the time of surgery ] [ Designated as safety issue: No ]
  • Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and the Correlation to Tumor Response [ Time Frame: Up to 15 months from time of registration ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: February 2011
Study Completion Date: September 2016
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1

Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.

Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.

Recommended mastectomy

Recommended adjuvant chemotherapy

-doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m2 for 14 days for 4 cycles)

Drug: Cisplatin Drug: Carboplatin Radiation: Radiation therapy Procedure: Mastectomy (recommended but not mandatory)

  Eligibility

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

Inclusion Criteria:

  • Patient must be > or = 18 years of age
  • Patient must be female
  • Patient must have primary invasive ductal breast adenocarcinoma that either:

    1. is newly diagnosed, without previous systemic treatment OR
    2. has failed to respond to < or = 4 cycles of neoadjuvant anthracycline based therapy as assessed by clinical exam or imaging studies (mammogram, ultrasound or breast MRI).
  • Patient's tumor must be classified as clinically stage T2, T3, or T4 with any N (NX, N0, N1, N2, or N3) prior to any neoadjuvant treatment.
  • Patient must have an ECOG Performance Status of < or = 1.
  • Patient must have adequate organ function defined as:

    1. Renal Function:

      1. CrCl ≥ 60 ml/min for patients receiving cisplatin
      2. CrCl ≥ 30 ml/min for patients receiving carboplatin.
    2. Liver Function:

      1. ALT, AST, ALK Phos < or = 1.5 x upper limit of institutional normal.
      2. Bilirubin < or = 1.5 x upper limit of institutional normal.
    3. Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.
    4. Hematologic:

      1. Absolute Neutrophil Count > or = 1500/mcl
      2. Platelets > or = 100,000/mcl
      3. Hemoglobin > or = 8.0 g/dl
  • Patient must be able and willing to sign informed consent document.

Exclusion Criteria:

  • Patient must not have evidence of distant metastasis present by CT, bone scan, or PET-CT. 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 at the discretion of the treating physician.
  • Patients having received neoadjuvant anthracycline based therapy must undergo restaging to exclude distant metastases prior to enrollment.
  • Patient must not have had any 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.
  • Patient's tumor must not express the following biomarkers or must have Allred score < 4 for: estrogen receptor, progesterone receptor, and is not Her2/neu amplified.
  • Women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
  • Patient must have > or = grade 2 peripheral neuropathy.
  • Patient must have a known hearing impairment (hearing loss or severe tinnitus). Hearing test will be performed at the discretion of the treating physician.
  • Patient must not have been previously treated with cisplatin or carboplatin for any condition.
  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: NCT01167192

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, M.D., Ph.D. Washington University School of Medicine
  More Information

Additional Information:
Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01167192     History of Changes
Other Study ID Numbers: 201310089 
Study First Received: July 14, 2010
Results First Received: September 8, 2016
Last Updated: September 8, 2016
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on December 09, 2016