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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01752686
• Other study ID #: Severance_BR_01
• Secondary ID: DA-TNBC
• Status: Not yet recruiting
• Phase: Phase 3
• First received: September 26, 2012
• Last updated: December 21, 2012
• Start date: March 2013
• Est. completion date: March 2018

Study information

• Verified date: December 2012
• Source: Severance Hospital
• Contact: Byeong Woo Park, MD, PhD
• Phone: 82-2-2228-8125
• Email: nobelg[@]yuhs.ac
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 587
• Est. completion date: March 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Neoplasms

Intervention

Drug:
• carboplatin
carboplatin as adjuvant chemotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	difference in gene expression pattern		up to 5 years	No
Primary	Disease-free survival (DFS)	To compare DFS between carboplatin and observation within non-pCR (complete remission) patients	up to 3 years	Yes
Secondary	overall survival	To compare overall survival (OS) between carboplatin and observation within non-pCR patients.	up to 5years	Yes
Secondary	pCR rate	To assess the pCR rate (no residual invasive carcinoma in primary breast and axillary lymph node) within total TNBC patients.	up to 3 years	Yes
Secondary	The percentage of patients who receive breast conserving surgery.	To assess the percentage of patients who receive breast conserving surgery within total triple negative breast cancer patients	up to 3years	Yes
Secondary	Number of adverse events	Number of adverse events in patients with non-pCR.	up to 3years	Yes