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Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer

Information source: Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Paclitaxel, Carboplatin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Shanghai Jiao Tong University School of Medicine

Official(s) and/or principal investigator(s):
Kunwei Shen, Dr, Principal Investigator, Affiliation: Shanghai Jiao Tong University School of Medicine

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.

Clinical Details

Official title: Phase 2 Study of Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer Patients

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: pathological complete remission (pCR) rate

Secondary outcome:

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

clinical response rate

Predictive markers of weekly paclitaxel plus carboplatin

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

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

Locations and Contacts

Fudan University Cancer Hospital, Shanghai, Shanghai 200032, China
Additional Information

Related publications:

Yang L, Li LD, Chen YD, Parkin DM. [Time trends, estimates and projects for breast cancer incidence and mortality in China]. Zhonghua Zhong Liu Za Zhi. 2006 Jun;28(6):438-40. Chinese.

Rouzier R, Perou CM, Symmans WF, Ibrahim N, Cristofanilli M, Anderson K, Hess KR, Stec J, Ayers M, Wagner P, Morandi P, Fan C, Rabiul I, Ross JS, Hortobagyi GN, Pusztai L. Breast cancer molecular subtypes respond differently to preoperative chemotherapy. Clin Cancer Res. 2005 Aug 15;11(16):5678-85.

Frasci G, Comella P, Rinaldo M, Iodice G, Di Bonito M, D'Aiuto M, Petrillo A, Lastoria S, Siani C, Comella G, D'Aiuto G. Preoperative weekly cisplatin-epirubicin-paclitaxel with G-CSF support in triple-negative large operable breast cancer. Ann Oncol. 2009 Jul;20(7):1185-92. doi: 10.1093/annonc/mdn748. Epub 2009 Feb 13.

Starting date: December 2007
Last updated: September 15, 2010

Page last updated: August 20, 2015

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