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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


Phase 3
20 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival (DFS)

Outcome Description:

To compare DFS between carboplatin and observation within non-pCR (complete remission) patients

Outcome Time Frame:

up to 3 years

Safety Issue:

Yes

Principal Investigator

Byeong Woo Park, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Severance Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

Severance_BR_01

NCT ID:

NCT01752686

Start Date:

March 2013

Completion Date:

March 2018

Related Keywords:

  • Breast Cancer
  • Triple negative breast cancer
  • adjuvant chemotherapy
  • Breast Neoplasms

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