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A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer

This study is not yet open for participant recruitment.
Verified December 2012 by Severance Hospital
Sponsor:
Information provided by (Responsible Party):
Byeong Woo Park, Severance Hospital
ClinicalTrials.gov Identifier:
NCT01752686
First received: September 26, 2012
Last updated: December 21, 2012
Last verified: December 2012
History of Changes
  Purpose

This study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy.


Condition Intervention Phase
Breast Cancer
 Drug: carboplatin
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Trial of Carboplatin as Adjuvant Chemotherapy Versus Observation in Triple Negative Breast Cancer With Pathologic Residual Cancer After Neoadjuvant Chemotherapy: POST-Neo Adjuvant Study

Resource links provided by NLM:

Drug Information available for: Carboplatin
U.S. FDA Resources

Further study details as provided by Severance Hospital:

Primary Outcome Measures:
  • Disease-free survival (DFS) [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
    To compare DFS between carboplatin and observation within non-pCR (complete remission) patients


Secondary Outcome Measures:
  • overall survival [ Time Frame: up to 5years ] [ Designated as safety issue: Yes ]
    To compare overall survival (OS) between carboplatin and observation within non-pCR patients.

  • pCR rate [ Time Frame: up to 3 years ] [ Designated as safety issue: Yes ]
    To assess the pCR rate (no residual invasive carcinoma in primary breast and axillary lymph node) within total TNBC patients.

  • The percentage of patients who receive breast conserving surgery. [ Time Frame: up to 3years ] [ Designated as safety issue: Yes ]
    To assess the percentage of patients who receive breast conserving surgery within total triple negative breast cancer patients

  • Number of adverse events [ Time Frame: up to 3years ] [ Designated as safety issue: Yes ]
    Number of adverse events in patients with non-pCR.


Other Outcome Measures:
  • difference in gene expression pattern [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 587
Study Start Date: March 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carboplatin chemotherapy
At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.
 Drug: carboplatin
carboplatin as adjuvant chemotherapy
Other Name: Adding adjuvant arm
No Intervention: Observation arm
In this observation arm, patients should be follow up with regular interval without treatment.

Detailed Description:

In Neo-adjuvant period Four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week intervals.

In POST Neo-adjuvant period

Randomization:

At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of breast cancer

    1. Female patients

    2. Histologically confirmed invasive breast cancer

      1. Primary tumor greater than 2cm diameter, measured by mammography and sonography
      2. Any N
    3. ER (estrogen receptor)/ PR (progesterone receptor) / HER2 (negative/ negative/ negative)(ER <1%, PR<1%, IHC 0, 1+ or FISH - in case of IHC (immuno-histochemistry) 2+)
    4. No evidence of metastasis (M0)
    5. No prior hormonal, chemotherapy or radiotherapy is allowed.
    6. No breast operation other than biopsy to make diagnosis is allowed.
    7. Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
    8. Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3
    9. Adequate renal function: Serum creatinine 1.5 mg/dl
    10. Adequate hepatic function: total bilirubin: 1.5 mg/dl, AST(aspartate aminotransferase)/ALT (alanine transaminase): 2 times normal, Alkaline phosphatase:2 times normal
    11. Written informed consent
    12. Normal mental function to understand and sign the consent
    13. Cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment.
    14. LVEF (left ventricular ejection fraction)50% by MUGA (multiple gated acquisition scan) or Echocardiogram taken within 1 mo of enrollment

Exclusion Criteria:

  1. Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
  2. Patients who underwent surgery for breast cancer
  3. Patients with a history of uncompensated congestive heart failure
  4. Patients with inflammatory breast cancer (T4d)
  5. Patients without primary tumor (T0)
  6. Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
  7. Known hypersensitivity to any of the study drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752686

Contacts
Contact: Byeong Woo Park, MD, PhD 82-2-2228-8125 nobelg@yuhs.ac

Sponsors and Collaborators
Severance Hospital
Investigators
Principal Investigator: Byeong Woo Park, MD, PhD Severance Hospital
  More Information

No publications provided

Responsible Party: Byeong Woo Park, Principal Investigator, Severance Hospital
ClinicalTrials.gov Identifier: NCT01752686     History of Changes
Other Study ID Numbers: Severance_BR_01, DA-TNBC
Study First Received: September 26, 2012
Last Updated: December 21, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Severance Hospital:
Triple negative breast cancer
adjuvant chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
 Carboplatin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013