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A Randomized Phase III Study of Docetaxel/ Epirubicin Versus Tailored Regimens as Neoadjuvant Chemotherapy for Stage II/III Breast Cancer With Tumor Size More Than 2 cm

Phase 3
20 Years
Open (Enrolling)
Breast Cancer, Chemotherapy

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Trial Information

A Randomized Phase III Study of Docetaxel/ Epirubicin Versus Tailored Regimens as Neoadjuvant Chemotherapy for Stage II/III Breast Cancer With Tumor Size More Than 2 cm

This is a multicenter randomized phase III trial. The purpose is to evaluate and compare the
pathological complete response (pCR) rates after neoadjuvant chemotherapy with tailored
chemotherapeutic regimens or standard chemotherapy for stage II/III breast cancer with tumor
size more than 2 cm.

For primary operable breast cancer, neoadjuvant chemotherapy is one of standard options.
Pathological complete response (pCR) was associated with significantly improved long-term
disease free and overall survival. Anthracycline/taxane-based chemotherapy regimens have
been studied extensively in prospective trials and are the most frequently prescribed
treatments in patients with breast cancer as neoadjuvant chemotherapy. Regimens that have
been tested in large multicenter phase III trials and yielded pCR rates of at around 15% and
up to 20% after 6 cycles of chemotherapy. Recent evidences have showed that the expression
of several proteins in the tumor samples such as tau, topoisomerase II alpha (topo II), and
ERCC1 can predict the tumor response to taxanes, anthracyclines, and platinums,
respectively. We hypothesized that select chemotherapeutic agent according the expressions
of drug sensitivity predictive biomarkers from patient's tumor sample may improve the
efficacy of breast cancer treatment.

In this randomized phase III trial, TE (Docetaxel/ epirubicin) will be given in control arm
since it is a highly active regimen for breast cancer. In the Tailored chemotherapy arm, 7
different combination chemotherapy regimens that containing 2 drugs among taxotere,
epirubicin, cisplatin, vinorelbine, and 5FU, will be given according to the expressions of
tumor biomarkers. The doses and schedules of those regimens are selected according published
1st line protocols for breast cancer. The primary endpoint is the pCR rate. After 4 cycles
of neoadjuvant chemotherapy, under the assumption of pCR rate of 15% in TE arm, to achieve
80% power at the 5% level (one side) of significance for the detection of a 15% increase of
pCR rate in tailored regimen arm, 134 patients in either arm should be included in the
study. If a 10% drop-out rate and multi-center study variation effect are considered,
totally 316 patients will be required.

Inclusion Criteria:

- Histologically confirmed invasive, but non-inflammatory, breast carcinoma, with
stage II or III disease (AJCC 7th ed)

- And, tumor size more than 2 cm in greatest diameter measured by estimated by CT scan
or MRI

- Documented Her2/neu negative , including score 0, 1+, or 2+ by immunohistochemistry

- No prior radiotherapy, hormonal therapy or chemotherapy for invasive breast cancer

- Performance status of ECOG 0, 1,

- Female with age older than 20 years

- Laboratory parameter

- Absolute neutrophil count (ANC) ≧1500/mm3

- Total bilirubin ≦2.0 times the upper limit of normal (ULM)

- AST or ALT ≦2.5 times the upper limit of normal (ULM)

- Platelets ≧100,000/mm3

- Serum creatinine ≦1.5 x ULM

- Fasting triglyceride ≧ 70 mg/dL

- Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria:

- Evidence of metastatic breast cancer or inflammatory breast cancer

- Bilateral breast cancer, metaplastic carcinoma, or mucinous carcinoma

- Known allergy to any of the study drugs or to agents containing Cremophor.

- Serious intercurrent infections or medical illnesses that are uncontrolled or the
control of which may be jeopardized by this therapy

- Psychiatric disorders or other conditions regarding the subject incapable of
complying with the requirements of the protocol

- Evidence of baseline sensory or motor neuropathy

- Pregnant or breast feeding women

- Previous or current systemic malignancy with the exception of curatively treated
non-melanoma skin cancer or cervical carcinoma in situ with a disease-free interval
of at least 5 years

Type of Study:


Study Design:

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

Outcome Measure:

To evaluate and compare the pathological complete response (pCR) rates

Outcome Time Frame:

operation after 4 cycles of neoadjuvant chemotherapy with tailored chemotherapeutic regimens or TE

Safety Issue:


Principal Investigator

Yen-Shen Lu, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, National Taiwan University Hospital


Taiwan: Department of Health

Study ID:




Start Date:

November 2008

Completion Date:

May 2013

Related Keywords:

  • Breast Cancer
  • Chemotherapy
  • breast ca
  • phase III
  • Tailored neoadjuvant chemotherapy
  • stage II/III
  • Breast Neoplasms