Neoadjuvant Paclitaxel Plus Epirubicin Versus Vinorelbine Plus Epirubicin in Breast Cancer With TEKT4 Variations

NCT02628613 | Completed Phase 2 DMC

• 1 other identifier: 20150309
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the efficiency and safety between paclitaxel combined with epirubicin and vinorelbine combined with epirubicin when used in neoadjuvant chemotherapy for locally advanced (IIb-IIIc) HER2-negative breast cancer with TEKT4 variations.

Conditions

Breast Cancer

Keywords

Breast cancer; Neoadjuvant chemotherapy; TEKT4

Outcome Measures

Primary Outcomes (1)

• pathologic Complete Response (pCR)

  pCR is defined as the absence of noninvasive tumor residuals in breast and axillary lymph nodes (ypT0/is ypN0) after neoadjuvant therapy.

  3 years

Secondary Outcomes (1)

• Objective Response Rate (ORR)

  3 years

Study Arms (2)

Paclitaxel plus Epirubicin

ACTIVE COMPARATOR

Paclitaxel plus Epirubicin for 4 cycles, paclitaxel 80 mg/m2 IV on day 1, 8 and 15, epirubicin 90 mg/m2 IV on day 1, and dosing interval is 21 days.

Drug: Paclitaxel plus Epirubicin

Vinorelbine plus Epirubicin

EXPERIMENTAL

Vinorelbine plus Epirubicin for 4 cycles, vinorelbine 25 mg/m2 IV on day 1, 8 and 15, epirubicin 90 mg/m2 IV on day 1, and dosing interval is 21 days.

Drug: Vinorelbine plus Epirubicin

Interventions

Vinorelbine plus Epirubicin DRUG

Evaluate the efficiency and safety of vinorelbine plus epirubicin as neoadjuvant chemotherapy in locally advanced HER2-negative breast cancer with TEKT4 variations

Vinorelbine plus Epirubicin

Paclitaxel plus Epirubicin DRUG

standard neoadjuvant chemotherapy

Paclitaxel plus Epirubicin

Eligibility Criteria

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

You may qualify if:

• Age: 18-70 years old
• Expected survival \> 12 months
• Baseline ECOG Performance Status rating 0-1
• Naïve to chemotherapy or hormonal treatments
• Radiologically confirmed and biopsy diagnosed invasive ductal carcinoma of breast and prepared to be treated surgically
• Locally advance breast cancer of stage IIb-IIIc
• HER-2 negative confirmed by immunohistochemistry, Ki-67≥20%
• TEKT4 variation confirmed by DNA sequencing
• No concurrent malignancy (except controlled cervical carcinoma in situ or basal cell carcinoma of skin)
• Patients have measurable lesions (according to RECIST v1.1 criteria)
• Intention to cooperate with baseline puncture and neoadjuvant therapy
• No advanced metastasis or metastasis involving brain or liver
• Adequate bone marrow function, blood routine examination shows neutrophil count ≥ 1.5x109/L, hemoglobin level ≥ 100 g/L, Platelets ≥ 100 x 109/L
• Adequate liver and kidney function, serum aminotransferase (AST) ≤ 60U/L, serum total bilirubin ≤ 2.5 times ULN, serum creatinine ≤110μmol/L, urea nitrogen ≤7.1mmol/L
• No coagulation abnormality

You may not qualify if:

• Previous regional or systemic treatment for breast cancer (include but not limited to chemotherapy, radiotherapy, targeted therapy, other clinical trials)
• Inflammatory breast cancer, bilateral breast cancer or breast cancer already with distant metastasis
• Complicated with uncontrolled lung disease, severe infection, active peptic ulcer, blood clotting disorders, severe uncontrolled diabetes, connective tissue disorders or bone marrow suppression, and intolerance to neoadjuvant therapy or related treatment
• Peripheral neuropathy \>1 degree caused by any reason
• History of congestive heart failure, uncontrolled or symptomatic angina, arrhythmias or history of myocardial infarction, refractory hypertension (systolic blood pressure \> 180 mmHg or diastolic blood pressure \> 100 mmHg);
• Breast cancer during lactation or pregnancy
• Unwillingly to receive baseline puncture or neoadjuvant therapy
• Mental illness or incompliance to treatment caused by other reasons
• Known history of severe hypersusceptibility to any agents used in the treatment protocol
• Patients received major surgery or suffered from severe trauma within 2 months of first administration
• Currently enroll or recently used (30 days within enrollment) other agent under research or involved in other trial
• Known to be infected with human immunodeficiency virus (HIV)
• Other circumstances considered to be inappropriate to be enrolled by researchers

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine; Epirubicin; Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Zhimin Shao, MD.PhD.

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 5, 2015
• First Posted: December 11, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: November 1, 2019

Record last verified: 2019-10

Locations

CN (1)