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Phase IIb Trial of Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Epirubicin as Neoadjuvant Treatment in Locally Advanced Triple-negative Breast Cancer

Phase 2
18 Years
70 Years
Open (Enrolling)
Triple Negative Breast Cancer

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Trial Information

Phase IIb Trial of Paclitaxel Plus Carboplatin Versus Paclitaxel Plus Epirubicin as Neoadjuvant Treatment in Locally Advanced Triple-negative Breast Cancer

It is know that triple-negative breast cancer(TNBC) is more aggressive than non-triple
negative breast cancer in both pathological features and clinical prognosis,and there is no
standard chemotherapy regimens especially for TNBC. NCCN guidelines recommends Paclitaxel or
Epirubicin based regimens as the preferred regimens both for the adjuvant chemotherapy and
the treatment of Recurrence and Metastatic breast cancer.The combination of these two drugs
is considered as a strong arrangement and therefore,is common used in Triple negative breast
cancer patients because of its poor prognosis.

According to the results of some retrospective studies, platinum-based chemotherapy
regimens showed a promising sensitive to Triple negative breast cancer patients compared
with regimens without platinum.

This study is to compare the effective of Paclitaxel combined with Epirubicin and Paclitaxel
plus Carboplatin in the neoadjuvant treatment for TNBC. And the investigators hypothesized
that paclitaxel combined with carboplatin is more sensitive to TNBC compared with Paclitaxel
plus Epirubicin,this study will also have a look into the relation of BRCA1 mutation and
sensitive to carboplatin.

Inclusion Criteria:

- Women aged from 18 to 70 years;

- WHO Performance status (ECOG) of 0 or 1

- Core biopsy histologically proven Ⅱa-Ⅲc phase breast cancer (regardless of the type);

- Immunohistochemisty(IHC):ER-,PR-,CerB2-;Triple negative (ER-PR-Her-2-) Hormone
receptor negativity is defined as ER<10%, PR<10% (IHC), HER2 negativity is defined as
IHC 0-1+, or [IHC 2+ and FISH or CISH negative];

- Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x
109/l, Hemoglobin > 9 g/dl);

- Adequate hepatic function: ASAT and ALAT £ 1.5 ULN alkaline phosphatases £ 2.5
ULN,total bilirubin £ 1,5 ULN;

- Adequate renal function: serum creatinine £ 1.5 ULN;

- Adequate cardiac function, LEVF value > 50% by Muga scan or echocardiography,and
electrocardiogram doe not show specific abnormality;

- Patients accepting contraception intake during the overall length of treatment if of
childbearing potential;

- Signed written informed consent.

Exclusion Criteria:

- Any tumor ³ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast

- ER+ or PR+ or Her-2 overexpression

- Any chemotherapy, hormonal therapy or radiotherapy before

- Previous cancer in the preceding 10 years;

- Patients already included in another therapeutic trial involving an experimental

- Patients with other concurrent severe and/or uncontrolled medical disease or
infection which could compromise participation in the study;

- LEVF < 50% (MUGA scan or echocardiography);

- Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart
failure, uncontrolled hypertension (>150/90), myocardial infarction or cerebral
vascular accidents) within 6 months prior to chemotherapy;

- Known prior severe hypersensitivity reactions to agents that will be received;

- Women who are pregnant or breastfeeding. Adequate birth control measures should be
taken during study treatment phase;

- Women with a positive pregnancy test en enrollment or prior to study drug

- Patients with any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the

- Individual deprived of liberty or placed under the authority of a tutor.

Type of Study:


Study Design:

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

Outcome Measure:

Pathology of specimens derived from the breast modified radical mastectomy/Breast-conserving surgery

Outcome Description:

After patients complete the neoadjuvant chemothreapy and receive the surguries,we can get their pathology ,and compare the pCR(pathological complete remission)rates of two amrs

Outcome Time Frame:

One week after the surgery

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute Hospital, Chinese Academy of Medical Sciences


China: Ethics Committee

Study ID:




Start Date:

January 2008

Completion Date:

July 2012

Related Keywords:

  • Triple Negative Breast Cancer
  • Triple Negative Breast Cancer
  • Neoadjuvant chemotherapy
  • Platinum
  • Breast Neoplasms