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

Phase 3

• Conditions: Breast Cancer
• Interventions: Drug: carboplatin

• Registration Number: NCT01752686
• Lead Sponsor: Severance Hospital

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2012-09-26
• Status Verified: 2012-12
• Study First Submitted QC: 2012-12-16
• Study First Posted: 2012-12-19
• Last Update Submitted: 2012-12-21
• Last Update Posted: 2012-12-25
• Study Start: 2013-03
• Primary Completion: 2017-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 587

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
carboplatin chemotherapy	carboplatin	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.

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS)	up to 3 years	To compare DFS between carboplatin and observation within non-pCR (complete remission) patients

Secondary Outcome Measures

Name	Time	Method
overall survival	up to 5years	To compare overall survival (OS) between carboplatin and observation within non-pCR patients.
pCR rate	up to 3 years	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.	up to 3years	To assess the percentage of patients who receive breast conserving surgery within total triple negative breast cancer patients
Number of adverse events	up to 3years	Number of adverse events in patients with non-pCR.