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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: November 9, 2016
Last verified: November 2016
July 14, 2010
November 9, 2016
February 2011
August 2012   (Final data collection date for primary outcome measure)
  • 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) ]
    • 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) ]
  • Determine whether radiation combined with platinum improves the clinical response rate in patients with locally advanced TN tumors [ Time Frame: 10 weeks ]
  • Obtain preliminary information on the relationship between tumor response in patients with locally advanced triple negative breast cancer treated with platinum-based chemoradiation correlates with deficiencies in DNA repair mechanisms [ Time Frame: 10 weeks ]
Complete list of historical versions of study NCT01167192 on ClinicalTrials.gov Archive Site
  • Time to Disease Progression [ Time Frame: Up to 5 years from registration ]
    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) ]
  • Determine the Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow [ Time Frame: Up to 15 months from registration ]
  • Overall Survival Rate [ Time Frame: Median follow-up was 59.9 months ]
  • 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) ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Determine the Effect of Neoadjuvant Chemoradiation on Tumor Response to Therapy [ Time Frame: 10 weeks ]
  • Determine time to disease progression and overall survival [ Time Frame: 5 years ]
  • Determine both surgical complications and medical toxicities with platinum-based chemoradiation [ Time Frame: 13 weeks ]
  • Determine the effect of neoadjuvant chemoradiation therapy in disseminated cancer cells in the bone marrow and correlation to tumor response [ Time Frame: 13 weeks ]
Not Provided
Not Provided
 
Neoadjuvant Platinum-based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer
Effect of Neoadjuvant Platinum-based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer: Clinical Outcome and Correlation to Biological Parameters
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: Cisplatin
  • Drug: Carboplatin
  • Radiation: Radiation therapy
  • Procedure: Mastectomy (recommended but not mandatory)
Experimental: Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation

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)

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
September 2016
August 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01167192
201310089
No
Not Provided
Not Provided
Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Rebecca Aft, M.D., Ph.D. Washington University School of Medicine
Washington University School of Medicine
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP