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

NCT01752686 | Unknown Phase 3 DMC

• 2 other identifiers: Severance_BR_01DA-TNBC
• Study Type: interventional
• Target: 587
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

Triple negative breast cancer; adjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

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

  up to 3 years

Secondary Outcomes (4)

• overall survival

  up to 5years

• pCR rate

  up to 3 years

• The percentage of patients who receive breast conserving surgery.

  up to 3years

• Number of adverse events

  up to 3years

Other Outcomes (1)

• difference in gene expression pattern

  up to 5 years

Study Arms (2)

carboplatin chemotherapy

EXPERIMENTAL

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.

Drug: carboplatin

Observation arm

NO INTERVENTION

In this observation arm, patients should be follow up with regular interval without treatment.

Interventions

carboplatin DRUG

carboplatin as adjuvant chemotherapy

Also known as: Adding adjuvant arm

carboplatin chemotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of breast cancer
• Female patients
• Histologically confirmed invasive breast cancer
• Primary tumor greater than 2cm diameter, measured by mammography and sonography
• Any N
• 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+)
• No evidence of metastasis (M0)
• No prior hormonal, chemotherapy or radiotherapy is allowed.
• No breast operation other than biopsy to make diagnosis is allowed.
• Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
• Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3
• Adequate renal function: Serum creatinine 1.5 mg/dl
• Adequate hepatic function: total bilirubin: 1.5 mg/dl, AST(aspartate aminotransferase)/ALT (alanine transaminase): 2 times normal, Alkaline phosphatase:2 times normal
• Written informed consent
• Normal mental function to understand and sign the consent

You may not qualify if:

• Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
• Patients who underwent surgery for breast cancer
• Patients with a history of uncompensated congestive heart failure
• Patients with inflammatory breast cancer (T4d)
• Patients without primary tumor (T0)
• Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
• Known hypersensitivity to any of the study drugs

Sponsors & Collaborators

• Severance Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Byeong Woo Park, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Byeong Woo Park, MD, PhD

CONTACT

82-2-2228-8125; nobelg@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 26, 2012
• First Posted: December 19, 2012
• Study Start: March 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2018
• Last Updated: December 25, 2012

Record last verified: 2012-12