Neoadjuvant Study of Nab-paclitaxel Plus Carboplatin in Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Shanghai Cancer Hospital, China
ClinicalTrials.gov Identifier:
NCT01625429
First received: June 19, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: nab-paclitaxel
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Single-center, Prospective, Phase II Study of Albumin-bound Paclitaxel (Nab-paclitaxel) and Carboplatin With or Without Trastuzumab (Herceptin) as Neoadjuvant Therapy in Locally Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Shanghai Cancer Hospital, China:

Primary Outcome Measures:
  • Pathological complete response rate [ Time Frame: Obtained within six months of the last patient's enrollment ] [ Designated as safety issue: No ]
    The percentage of patients with a pathological complete response after neoadjuvant therapy


Secondary Outcome Measures:
  • Overall response rate [ Time Frame: Obtained within six months of the last patient's enrollment ] [ Designated as safety issue: No ]
    The percentage of patients with complete response or partial response after neoadjuvant therapy

  • Three-year disease free survival [ Time Frame: Obtained within 42 months after last patient's enrollment ] [ Designated as safety issue: No ]
    The percentage of patients who survive without breast cancer recurrence or metastases three years after surgery

  • Overall survival [ Time Frame: Obtained around 5 years after the last patient's erollment ] [ Designated as safety issue: No ]
    The overall survival time of all patients enrolled in the study presented by survival curve and median value

  • Safety [ Time Frame: Obtained around six months after the last patient's enrollment ] [ Designated as safety issue: Yes ]
    List and frequencies of adverse events occured during and one-month after the investigational drug treatment


Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: neoadjuvant Drug: nab-paclitaxel
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
Other Names:
  • Abraxane
  • Herceptin

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625429

Locations
China
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Cancer Hospital, China
Investigators
Principal Investigator: Zhimin Shao, MD Fudan University
  More Information

No publications provided

Responsible Party: Shanghai Cancer Hospital, China
ClinicalTrials.gov Identifier: NCT01625429     History of Changes
Other Study ID Numbers: ABX-1201
Study First Received: June 19, 2012
Last Updated: November 8, 2012
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 23, 2014