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Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01203267
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : September 16, 2010
Fudan University
Ruijin Hospital
Information provided by:
Shanghai Jiao Tong University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Paclitaxel, Carboplatin Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer Patients
Study Start Date : December 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. pathological complete remission (pCR) rate [ Time Frame: after 4 cycles of preoperative treatment ]

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

  2. clinical response rate [ Time Frame: after 4 cycles of preoperative therapy ]
  3. Predictive markers of weekly paclitaxel plus carboplatin [ Time Frame: after 4 cycles of preoperative treatment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01203267

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China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Fudan University
Ruijin Hospital
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Principal Investigator: Kunwei Shen, Dr Shanghai Jiao Tong University School of Medicine
Publications of Results:
Other Publications:
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Responsible Party: Kunwei Shen/Shanghai Jiao Tong University, Shanghai Jiao Tong University Identifier: NCT01203267    
Other Study ID Numbers: DXK200801
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: September 16, 2010
Last Verified: November 2007
Keywords provided by Shanghai Jiao Tong University School of Medicine:
Breast Neoplasms
Pathological Complete Remission
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action