Tailored Neoadjuvant Chemotherapy for Stage II/III Breast Cancer With Tumor Size More Than 2 cm

NCT00776724 | Completed Phase 3 DMC

• 1 other identifier: 200803006M
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multi-center 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.

Conditions

Breast Cancer; Chemotherapy

Keywords

breast ca; phase III; Tailored neoadjuvant chemotherapy; stage II/III

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (1)

• To evaluate the overall clinical response rate

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

Study Arms (2)

1

ACTIVE COMPARATOR

docetaxel-epirubicin for 4 cycles before surgery

Drug: Taxotere , Epirubicin

2

EXPERIMENTAL

Tailored regimens, base on immunohistochemical study of the tumor biopsy tissue, for 4 cycles before surgery.

Drug: E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TP

Interventions

Taxotere , Epirubicin DRUG

Taxotere 70 mg/m2 1hr iv infusion / Epirubicin 90 mg/m2 (TE) iv infusion on day 1.

1

E-HDFL,EP,TE,N-HDFL,NP,T-HDFL,TP DRUG

Tau+ topo II+ ERCC1+ : Epi 45mg/m2 iv / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8. Tau+ topo II+ ERCC1- : Epi 45mg/m2 iv/ Cis 35mg/m2 24 hrs iv infusion day 1 and 8. Tau+ topo II- ERCC1+ : Vin 25mg/m2 iv / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8. Tau+ topo II- ERCC1- : Cis 35mg/m2 24 hrs infusion / Vin 25mg/m2 iv day 1 and 8. Tau- topo II+ ERCC1+ : Docetaxel 70 mg/m2 / Epirubicin 90 mg/m2 on day 1. Tau- topo II+ ERCC1- : Docetaxel 70 mg/m2 / Epirubicin 90 mg/m2 on day 1. Tau- topo II- ERCC1+ : Tax 35mg/m2 1hr infusion / 5FU 2000mg/m2 + Lv 300mg/m2 24 hrs infusion, day 1 and 8. Tau- topo II- ERCC1- : Tax 35mg/m2 1hr infusion / Cis 35mg/m2 24 hrs infusion day 1 and 8.

2

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Yen-Shen Lu, M.D., Ph.D.

  Department of Oncology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Chiun-Sheng Hunag, MD,PhD

  Department of Surgery, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2008
• First Posted: October 21, 2008
• Study Start: May 29, 2008
• Primary Completion: November 30, 2014
• Study Completion: April 19, 2017
• Last Updated: May 6, 2019

Record last verified: 2019-05

Locations

TW (1)