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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03147963
• Other study ID #: ZCHBC0011
• Status: Recruiting
• Phase: Phase 2
• First received: May 4, 2017
• Last updated: May 7, 2017
• Start date: December 20, 2015
• Est. completion date: December 30, 2019

Study information

• Verified date: May 2017
• Source: Zhejiang Cancer Hospital
• Contact: Xiaojia WANG, MD,PHD
• Phone: 8613906500190
• Email: wxiaojia0803[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel will be given until progression or patient intolerance

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

References & 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. Erratum in: J Clin Oncol. 2003 May 15;21(10):2048. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival(OS)	The time elapsed between enrolling and death from any cause	From date of enrolling until the date of death from any cause, assessed up to 5 years
Secondary	Clinical benefit rate(CBR)	The response is CR+PR+SD = 24 weeks	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	Quality of life(QOL)	Score change from enrolling to progression disease or death according EORTC QLQ-C30.The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.	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	Number of participants with Grade 3/4 adverse events	Number of participants with Grade 3/4 adverse events of the two groups was assessed in accordance with the common terminology criteria (NCI CTC AE) version 4.0.	From date of enrolling until the date of 1 month of stop treatment, assessed up to 5 years