Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Guangdong General Hospital
Sponsor:
Information provided by (Responsible Party):
Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT02059876
First received: February 7, 2014
Last updated: February 11, 2014
Last verified: November 2013
  Purpose

The purpose of this study is to determine the efficacy and safety of dose-dense(biweekly) carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: carboplatin and paclitaxel and or without trastuzumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • pathologic complete response [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carboplatin and paclitaxel ± trastuzumab
dose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer.
Drug: carboplatin and paclitaxel and or without trastuzumab
dose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer
Other Names:
  • paclitaxel (Taxol)
  • trastuzumab (Herceptine)

Detailed Description:

Dose-dense regimens have been shown to improve outcome when given as adjuvant therapy to patients with breast cancer compared with their three weekly counterparts. It is unknown if dose dense neoadjuvant therapy will improve survival in resectable breast cancer. This study is to evaluate the efficacy and safety of dose-dense(biweekly) carboplatin and paclitaxel ± trastuzumab as neoadjuvant treatment in early breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed invasive breast carcinoma
  • Clinical stage Ⅱ-ⅢB
  • Patients must have measurable disease as defined by palpable lesion with both diameters ≥2cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension ≥2cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, xrays and scans must be done within 28 days of study entry.
  • Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
  • Normal (greater than 50%) left ventricular ejection fraction (LVEF) by echocardiography
  • Signed informed consent
  • Adequate organ function within 2 weeks of study entry:

    1. Absolute neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count >100,000/mm3
    2. Total bilirubin < upper limit of normal
    3. Creatinine < 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) >50mL/min using the Cockcroft Gault equation
    4. serum glutamate oxaloacetate transaminase(SGOT)(AST) or serum glutamic oxaloacetic transaminase(SGPT)(ALT) and Alkaline Phosphatase must be within the range allowing for eligibility
  • Patients must be over 18 years old.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation.

Exclusion Criteria:

  • Metastatic disease
  • Prior chemotherapy, hormonal therapy, biologic therapy, investigational agent, targeted therapy or radiation therapy for current breast cancer. Patients with history of breast cancer greater than 5 years from initial diagnosis are eligible for the study. Patients may not have received anthracycline-based chemotherapy in the past. Patients with history of ductal carcinoma in situ(DCIS) are eligible if there were treated with surgery alone.
  • History of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain disease free for greater than five years are eligible.
  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: NCT02059876

Contacts
Contact: Kun Wang, MD 00862083827812 ext 50910 gzwangkun@126.com

Locations
China, Guangdong
Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China
Contact: Liming Yao    00862083827812 ext 20984    13149395530@163.com   
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Principal Investigator: Kun Wang, MD Guangdong General Hospital
  More Information

Publications:
Responsible Party: Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT02059876     History of Changes
Other Study ID Numbers: 20120608
Study First Received: February 7, 2014
Last Updated: February 11, 2014
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
breast cancer
dose dense
neoadjuvant treatment
pathologic complete response

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

ClinicalTrials.gov processed this record on September 16, 2014