Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203267
• Other study ID #: DXK200801
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2010
• Last updated: September 15, 2010
• Start date: December 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2007
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine	Fudan University, Ruijin Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Chen XS, Nie XQ, Chen CM, Wu JY, Wu J, Lu JS, Shao ZM, Shen ZZ, Shen KW. Weekly paclitaxel plus carboplatin is an effective nonanthracycline-containing regimen as neoadjuvant chemotherapy for breast cancer. Ann Oncol. 2010 May;21(5):961-7. doi: 10.1093/an — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathological complete remission (pCR) rate		after 4 cycles of preoperative treatment	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	From the first dose of neoadjuvant chemotherapy to definitive surgery or disease progression	4 months during neoadjuvant therapy	Yes
Secondary	clinical response rate		after 4 cycles of preoperative therapy	No
Secondary	Predictive markers of weekly paclitaxel plus carboplatin		after 4 cycles of preoperative treatment	No