Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Fudan University
Ruijin Hospital
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01203267
First received: September 14, 2010
Last updated: September 15, 2010
Last verified: November 2007
  Purpose

The purpose of this study is to evaluate the pathological complete response (pCR) rate in breast cancer patients treated with weekly paclitaxel plus carboplatin preoperative regimen.


Condition Intervention Phase
Breast Cancer
Drug: Paclitaxel, Carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • pathological complete remission (pCR) rate [ Time Frame: after 4 cycles of preoperative treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 4 months during neoadjuvant therapy ] [ Designated as safety issue: Yes ]
    From the first dose of neoadjuvant chemotherapy to definitive surgery or disease progression

  • clinical response rate [ Time Frame: after 4 cycles of preoperative therapy ] [ Designated as safety issue: No ]
  • Predictive markers of weekly paclitaxel plus carboplatin [ Time Frame: after 4 cycles of preoperative treatment ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: December 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paclitaxel plus carboplatin (PCb) Arm
4 cycles of neoadjuvant paclitaxel plus carboplatin
Drug: Paclitaxel, Carboplatin
Paclitaxel 80 mg/m2, carboplatin AUC of 2 mg/min/ml, given on days 1, 8 and 15 of a 28-day cycle.

Detailed Description:

Breast cancer is the leading cause of cancer in women in China. Preoperative chemotherapy for treatment of locally advanced breast cancer has become a standard therapy. Results from neoadjuvant trials have shown that pathological complete response (pCR) is an independent predictor of outcome. Paclitaxel was introduced into clinical practice in the early 1990s and has demonstrated good activity in the adjuvant and metastatic settings. Platinum complexes, like cisplatin and carboplatin, are active in a wide range of solid tumors. Paclitaxel combined with carboplatin has shown great activity in ovarian and nonsmall- cell lung cancer treatment. In addition, the overall response rate of paclitaxel plus carboplatin was between 53% and 62% in the first-line treatment of metastatic breast cancer. This study will evaluate the pCR rate of weekly paclitaxel plus carboplatin as preoperative treatment for breast cancer patients.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged ≥ 18 years and < 70 years
  • Karnofsky performance status (KPS) ≥ 70
  • At least one measurable disease according to the RECIST. histologically confirmed invasive breast cancer (excluding inflammatory breast cancer), large operable (T≥3 cm and N0-1) or locally advanced breast cancer (T3-4N0-3 or T0-4N2-3)
  • Biopsy specimens are available for ER, PgR and Her2 analysis
  • Adequate bone marrow function: Neutrophil ≥ 1.5*109/L; Hb ≥ 100g/L; PLT ≥ 100*109/L
  • An estimated life expectancy of at least 12 months
  • Willing to take biopsy before neoadjuvant chemotherapy and patients must be accessible for treatment and follow-up
  • Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study
  • Written informed consent according to the GCP

Exclusion Criteria:

  • Prior systemic or loco-regional treatment of breast cancer, including chemotherapy
  • Metastatic breast cancer
  • With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
  • Patients with medical conditions that indicate intolerant to neoadjuvant therapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitis, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
  • inadequate liver function (bilirubin > 1.0 times upper normal limit [UNL] and ALT and/or AST> 1.5 UNL associated with alkaline phosphatase > 2.5 UNL; inadequate renal function (creatinine > 1.0 times UNL and in case of limit value, Creatinine clearance < 60 ml/min)
  • Contraindication for using dexamethasone
  • History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension (systolic BP > 180 mmHg or diastolic BP > 100 mmHg)
  • Has peripheral neuropathy ≥ grade 1
  • Patient is pregnant or breast feeding
  • Known severe hypersensitivity to any drugs in this study
  • Treatment with any investigational drugs within 30 days before the beginning of study treatment
  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: NCT01203267

Locations
China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Fudan University
Ruijin Hospital
Investigators
Principal Investigator: Kunwei Shen, Dr Shanghai Jiao Tong University School of Medicine
  More Information

Publications:
Responsible Party: Kunwei Shen/Shanghai Jiao Tong University, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT01203267     History of Changes
Other Study ID Numbers: DXK200801
Study First Received: September 14, 2010
Last Updated: September 15, 2010
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Breast Neoplasms
Neoadjuvant
Chemotherapy
Paclitaxel
Carboplatin
Pathological Complete Remission

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

ClinicalTrials.gov processed this record on October 23, 2014