Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer

NCT01203267 | Completed Phase 2

• 1 other identifier: DXK200801
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Neoplasms; Neoadjuvant; Chemotherapy; Paclitaxel; Carboplatin; Pathological Complete Remission

Outcome Measures

Primary Outcomes (1)

• pathological complete remission (pCR) rate

  after 4 cycles of preoperative treatment

Secondary Outcomes (3)

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

  4 months during neoadjuvant therapy

• clinical response rate

  after 4 cycles of preoperative therapy

• Predictive markers of weekly paclitaxel plus carboplatin

  after 4 cycles of preoperative treatment

Study Arms (1)

paclitaxel plus carboplatin (PCb) Arm

EXPERIMENTAL

4 cycles of neoadjuvant paclitaxel plus carboplatin

Drug: Paclitaxel, Carboplatin

Interventions

Paclitaxel, Carboplatin DRUG

Paclitaxel 80 mg/m2, carboplatin AUC of 2 mg/min/ml, given on days 1, 8 and 15 of a 28-day cycle.

paclitaxel plus carboplatin (PCb) Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Fudan University: collaborator
• Ruijin Hospital: collaborator

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (4)

• 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.

  PMID: 17152490 BACKGROUND

• 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. doi: 10.1158/1078-0432.CCR-04-2421.

  PMID: 16115903 BACKGROUND

• 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.

  PMID: 19218307 BACKGROUND

• 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/annonc/mdq041. Epub 2010 Mar 8.

  PMID: 20211870 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Interventions

CP protocol

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

Study Officials

• Kunwei Shen, Dr

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: September 16, 2010
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: September 16, 2010

Record last verified: 2007-11

Locations

CN (1)