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

NCT02059876 | Unknown Phase 2 DMC

• 1 other identifier: 20120608
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer; dose dense; neoadjuvant treatment; pathologic complete response

Outcome Measures

Primary Outcomes (1)

• pathologic complete response

  one year

Study Arms (1)

carboplatin and paclitaxel ± trastuzumab

EXPERIMENTAL

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

Interventions

carboplatin and paclitaxel and or without trastuzumab DRUG

dose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer

Also known as: paclitaxel (Taxol), trastuzumab (Herceptine)

carboplatin and paclitaxel ± trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 12668651 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Interventions

Carboplatin; Paclitaxel; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Kun Wang, MD

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Wang, MD

CONTACT

00862083827812; gzwangkun@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 11, 2014
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 12, 2014

Record last verified: 2013-11

Locations

CN (1)