Neoadjuvant Study of Nab-paclitaxel Plus Carboplatin in Breast Cancer

NCT01625429 | Unknown Phase 2

• 1 other identifier: ABX-1201
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, prospective, single arm phase II study to evaluate the efficacy and safety of nab-paclitaxel plus carboplatin (with trastuzumab for HER-2 positive patients) as neoadjuvant therapy in operable locally advanced breast cancer patients. The primary objective is pCR. The secondary objectives include ORR, 3-yr DFS, OS and safety. The sample size is 30.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate

  The percentage of patients with a pathological complete response after neoadjuvant therapy

  Obtained within six months of the last patient's enrollment

Secondary Outcomes (4)

• Overall response rate

  Obtained within six months of the last patient's enrollment

• Three-year disease free survival

  Obtained within 42 months after last patient's enrollment

• Overall survival

  Obtained around 5 years after the last patient's erollment

• Safety

  Obtained around six months after the last patient's enrollment

Study Arms (1)

neoadjuvant

EXPERIMENTAL

Drug: nab-paclitaxel

Interventions

nab-paclitaxel DRUG

nab-paclitaxel 125mg/m2, day 1, 8, 15, q4w; carboplatin AUC 2, day 1, 8, 15, q4w; for HER-2 positive patients: trastuzumab loading dose 4mg/kg, then 2mg/kg, day 1, 8, 15, 22, q4w. All patients will receive up to four cycles except for unacceptable toxicity

Also known as: Abraxane, Herceptin

neoadjuvant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, between 18 and 70 years old
• Life expectancy is more than 12 months
• Breast MRI or ultrasound confirmd tumor over 3cm and biopsy comfirned invasive breast caner of stage II-III (inflammatory breast cancer excluded)
• Not accompanied with other malignancies（except for controlled carcinoma in situ of the cervix or skin basal-cell carcinoma）
• A normal bone marrow: absolute neutrophil count≥1.5\*10E9/L, hemoglobin≥100g/L, PLT≥100\*10E9/L
• Normal liver and renal functions: AST≤60U/L, total biliruin≤1.5\*upper limit of normal, serum creatinine≤110umol/L, urea nitrogen≤7.1mmol/L
• Normal blood coagulation function
• ECOG performance status of 0-1
• Willing to coordinate with a punch biopsy before treatment and accept neoadjuvant therapy
• Women of child-producing potential must agree to use effective contraceptive methods during the study, and a negative serum or urine pregnancy test must be obtained within 7 days prior to administration of the drugs
• Written informed consent
• For HER-2 positive patients, the HER-2 status must be determined by ICH +++ or FISH/CISH. For patients treated with trastuzumb, LVEF≥55% by ultrasonic cardiogram or MUGA scan

You may not qualify if:

• Previous systematic or local therapy including chemotherapy for breast cancer
• Distant metastases of breast cancer are observed
• Concurrent uncontrolled lung disease, severe sepsis, active peptic ulcer requring treatment, blood coagulation disorders, serious uncontrolled diabetes, connective tissue disease or bone marrow depression, unable to tolerate neoadjuvant therapy and related treatment
• \>Grade 1 peripheral neuropathy caused by any reason
• History of CHF, uncontrolled symptomatic angina, history of arrhythmias or myocardial infarction, poorly controlled hypertension (systolic pressure \> 180mmHg or diastlic pressure \> 100 mmHg)
• Lactational or gestational breast cancer
• Not willing to accept a punch biopsy before treatment and neoadjuvant therapy
• Psychopath or any other reasons that would preclude compliane with treatment
• Known serious allergy to any of the study drugs or excipients
• Participation in another study requiring administration of an in investigational drug or biological agent at present or recently (within the last 30 days prior to screening visit)

Sponsors & Collaborators

• Shanghai Cancer Hospital, China: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Trastuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Study Officials

• Zhimin Shao, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: June 1, 2017
• Last Updated: November 9, 2012

Record last verified: 2012-11

Locations

CN (1)