Clinical trial NCT01752686: A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Triple negative breast cancer
adjuvant chemotherapy
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 587
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: up to 3 years
Secondary outcomes:
measure: overall survival
timeFrame: up to 5years
measure: pCR rate
timeFrame: up to 3 years
measure: The percentage of patients who receive breast conserving surgery.
timeFrame: up to 3years
measure: Number of adverse events
timeFrame: up to 3years
Other outcomes:
measure: difference in gene expression pattern
timeFrame: up to 5 years
Locations:
Study officials:
affiliation: Severance Hospital
name: Byeong Woo Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: