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Neoadjuvant Study of Nab-paclitaxel Plus Carboplatin in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01625429
Recruitment Status : Unknown
Verified November 2012 by Shanghai Cancer Hospital, China.
Recruitment status was:  Active, not recruiting
First Posted : June 21, 2012
Last Update Posted : November 9, 2012
Information provided by (Responsible Party):
Shanghai Cancer Hospital, China

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: nab-paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2012
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Pathological complete response rate [ Time Frame: Obtained within six months of the last patient's enrollment ]
    The percentage of patients with a pathological complete response after neoadjuvant therapy

Secondary Outcome Measures :
  1. Overall response rate [ Time Frame: Obtained within six months of the last patient's enrollment ]
    The percentage of patients with complete response or partial response after neoadjuvant therapy

  2. Three-year disease free survival [ Time Frame: Obtained within 42 months after last patient's enrollment ]
    The percentage of patients who survive without breast cancer recurrence or metastases three years after surgery

  3. Overall survival [ Time Frame: Obtained around 5 years after the last patient's erollment ]
    The overall survival time of all patients enrolled in the study presented by survival curve and median value

  4. Safety [ Time Frame: Obtained around six months after the last patient's enrollment ]
    List and frequencies of adverse events occured during and one-month after the investigational drug treatment

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01625429

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

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Responsible Party: Shanghai Cancer Hospital, China Identifier: NCT01625429     History of Changes
Other Study ID Numbers: ABX-1201
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: November 9, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological