Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
carboplatin and paclitaxel and or without trastuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, dose dense, neoadjuvant treatment, pathologic complete response
Eligibility 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:
- Absolute neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count >100,000/mm3
- Total bilirubin < upper limit of normal
- Creatinine < 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) >50mL/min using the Cockcroft Gault equation
- 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.
Sites / Locations
- Guangdong General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
carboplatin and paclitaxel ± trastuzumab
Arm Description
dose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer.
Outcomes
Primary Outcome Measures
pathologic complete response
Secondary Outcome Measures
Full Information
NCT ID
NCT02059876
First Posted
February 7, 2014
Last Updated
February 11, 2014
Sponsor
Guangdong Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02059876
Brief Title
Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer
Official Title
A Pilot Study of Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, dose dense, neoadjuvant treatment, pathologic complete response
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
carboplatin and paclitaxel ± trastuzumab
Arm Type
Experimental
Arm Description
dose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer.
Intervention Type
Drug
Intervention Name(s)
carboplatin and paclitaxel and or without trastuzumab
Other Intervention Name(s)
paclitaxel (Taxol), trastuzumab (Herceptine)
Intervention Description
dose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer
Primary Outcome Measure Information:
Title
pathologic complete response
Time Frame
one year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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:
Absolute neutrophil count >1500/mm3, Hgb >9.0 g/dl and platelet count >100,000/mm3
Total bilirubin < upper limit of normal
Creatinine < 1.5 mg/dL or calculated cranial cruciate ligament (CrCL) >50mL/min using the Cockcroft Gault equation
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kun Wang, MD
Phone
00862083827812
Ext
50910
Email
gzwangkun@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kun Wang, MD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liming Yao
Phone
00862083827812
Ext
20984
Email
13149395530@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
12668651
Citation
Citron ML, Berry DA, Cirrincione C, Hudis C, Winer EP, Gradishar WJ, Davidson NE, Martino S, Livingston R, Ingle JN, Perez EA, Carpenter J, Hurd D, Holland JF, Smith BL, Sartor CI, Leung EH, Abrams J, Schilsky RL, Muss HB, Norton L. Randomized trial of dose-dense versus conventionally scheduled and sequential versus concurrent combination chemotherapy as postoperative adjuvant treatment of node-positive primary breast cancer: first report of Intergroup Trial C9741/Cancer and Leukemia Group B Trial 9741. J Clin Oncol. 2003 Apr 15;21(8):1431-9. doi: 10.1200/JCO.2003.09.081. Epub 2003 Feb 13. Erratum In: J Clin Oncol. 2003 Jun 1;21(11):2226.
Results Reference
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Dose-dense (Biweekly) Carboplatin Plus Paclitaxel With or Without Trastuzumab as Neoadjuvant Treatment for Breast Cancer
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