Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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

September 26, 2012
December 21, 2012
March 2013
March 2017   (final data collection date for primary outcome measure)
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
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 patients
Complete list of historical versions of study NCT01752686 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 recieve breast conserving surgery. [ Time Frame: up to 3years ] [ Designated as safety issue: Yes ]
    To assess the percentage of patients who recieve breast conserving surgery within total TNBC patients
  • safety profiles [ Time Frame: up to 3years ] [ Designated as safety issue: Yes ]
    To assess the safety profiles in patients with non-pCR.
difference in gene expression pattern [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
Same as current
 
A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: carboplatin
carboplatin as adjuvant chemotherapy
Other Name: Adding adjuvant arm
  • 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.
    Intervention: Drug: carboplatin
  • No Intervention: Observation arm
    In this observation arm, patients should be follow up with regular interval without treatment.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
587
March 2018
March 2017   (final data collection date for primary outcome measure)

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
Female
20 Years and older
No
Contact: Byeong Woo Park, MD, PhD 82-2-2228-8125 nobelg@yuhs.ac
Not Provided
 
NCT01752686
Severance_BR_01, DA-TNBC
Yes
Byeong Woo Park, Severance Hospital
Severance Hospital
Not Provided
Principal Investigator: Byeong Woo Park, MD, PhD Severance Hospital
Severance Hospital
December 2012

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