Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer

NCT03147963 | Unknown Phase 2 DMC

• 1 other identifier: ZCHBC0011
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-Weeks Regimen

Conditions

Breast Cancer

Keywords

therapy; breast cancer; docetaxel; metastasis

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  Progression-free survival (PFS) is defined as the time elapsed between enrolling and tumor progression or death from any cause

  From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years

Secondary Outcomes (4)

• Overall survival(OS)

  From date of enrolling until the date of death from any cause, assessed up to 5 years

• Clinical benefit rate(CBR)

  From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 5 years

• Quality of life（QOL）

  From date of enrolling until the date of first documented progression or date of death from any cause, whichever came first，assessed up to 5 years

• Number of participants with Grade 3/4 adverse events

  From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years

Study Arms (2)

Docetaxel 2-Weeks regimen group

EXPERIMENTAL

Docetaxel injection 50mg/m2,iv,d1,every 2 weeks

Drug: Docetaxel

Docetaxel 3-Weeks regimen group

ACTIVE COMPARATOR

Docetaxel injection 75mg/m2,iv,d1,every 3 weeks

Drug: Docetaxel

Interventions

Docetaxel DRUG

Docetaxel will be given until progression or patient intolerance

Docetaxel 2-Weeks regimen group; Docetaxel 3-Weeks regimen group

Eligibility Criteria

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

You may qualify if:

• Signed informed consent
• The age is Above 18 years of age, \<70 years old
• The diagnosis of breast cancer was confirmed by cytological examination or pathological examination. HER2-negative
• Clinical stage was metastatic breast cancer or locally advanced breast cancer.
• Must have at least one measurable lesion, according to RECISTv1.1.
• Eastern Cooperative Oncology Group performance status (ECOG PS)=0\~2
• Docetaxel or paclitaxel can been used in initial treatment or in the past for locally advanced, recurrent or metastatic lesions,if used must been proved effective, and recent progress over 6 months.
• The basic function of normal bone marrow
• Functions of liver and kidney is normal
• Expectation of life is more than 3 months
• Agreed to take contraceptive measures during treatment

You may not qualify if:

• The patient had a history of allergy to taxanes or their components.
• Recent progress of taxanes in 6 months.
• In the elution period of other chemotherapy regimens.
• Severe coagulopathy.
• HER2 positive breast cancer
• Previous toxicity was not recovered to 0-1 degrees
• Central nervous system metastasis had not Controlled yet
• Pregnancy or lactation
• There are uncontrolled infection, myocardial infarction, thrombosis, etc.
• There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
• HIV infection
• Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;
• Researchers believe that is not suitable for the study

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

RECRUITING

Related Publications (1)

• Nabholtz JM, Falkson C, Campos D, Szanto J, Martin M, Chan S, Pienkowski T, Zaluski J, Pinter T, Krzakowski M, Vorobiof D, Leonard R, Kennedy I, Azli N, Murawsky M, Riva A, Pouillart P; TAX 306 Study Group. Docetaxel and doxorubicin compared with doxorubicin and cyclophosphamide as first-line chemotherapy for metastatic breast cancer: results of a randomized, multicenter, phase III trial. J Clin Oncol. 2003 Mar 15;21(6):968-75. doi: 10.1200/JCO.2003.04.040.

  PMID: 12637459 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Xiaojia WANG, MD,PHD

  Zhejiang Cance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaojia WANG, MD,PHD

CONTACT

8613906500190; wxiaojia0803@163.com

Ping HUANG, MD

CONTACT

8613685766632; zlyyhp@163.com

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: attending doctor

Model Details: patients was divided 1:1 into docetaxel 2-weeks regimen group and docetaxel 3-weeks regimen group

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 10, 2017
• Study Start: December 20, 2015
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: May 10, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)