Neoadjuvant Study of Nab-paclitaxel Plus Carboplatin in Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Shanghai Cancer Hospital, China
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
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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:
|
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 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 Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Trastuzumab Carboplatin Paclitaxel |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 18, 2013