Platinum Rechallenge in Patients With Platinum-sensitive mTNBC

Metastatic Breast Cancer Clinical Trial

Official title:

Platinum Retreated in Second- or Third-line Patients With Platinum Sensitive Metastatic Triple Negative Breast Cancer (Randomised, Phase II, NPN Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02607215
• Other study ID #: Fudan BR2015-19
• Status: Recruiting
• Phase: Phase 2
• Start date: November 2015
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: Fudan University
• Contact: Xichun Hu, MD, PhD
• Phone: 64175590
• Email: huxicun[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Platinum Retreated in Patients with Platinum Sensitive mTNBC

Description:

Platinum Retreated in Second- or Third-line Patients with Platinum Sensitive Metastatic Triple Negative Breast Cancer (randomised, phase II, NPN trial)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Females with age between 18 and 70 years old

2. Performance status no more than 2

3. Life expectancy longer than 3 months

4. Histological proven unresectable recurrent or advanced breast cancer

5. Triple-negative for estrogen receptor (ER), progestogen receptor (PR), and human epithelial receptor-2 (HER2) by immunohistochemistry (ER <1%, PR <1% and Her2 negative). A negative Her2 gene amplification should be verified by FISH test for those patients with Her2 (2+).

6. Patients must have progressed after 1or 2 prior chemotherapy regimens for metastatic disease, cis/carbo-platin pretreated only 1 previous line prior to randomisation. Platinum sensitive in this study is defined as complete or partial or stable disease following completion (a minimum of 4 treatment cycles) of previous platinum-based chemotherapy and disease progression greater than 3 months after completion of their last dose of platinum chemotherapy (last dose).

7. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1)

8. Radiation therapy within 4 weeks prior to enrollment

9. All patients enrolled are required to have adequate hematologic, hepatic, and renal function

10. Be able to understand the study procedures and sign informed consent.

Exclusion Criteria:

1. Patients had prior treatment with vinorelbine

2. Pregnant or lactating women, women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study

3. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to the registration

4. Treatment with an investigational product within 4 weeks before the first treatment

5. Severe cardiopulmonary insufficiency, severe hepatic and renal dysfunction

6. Uncontrolled serious infection

7. Other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Vinorelbine
25 mg/m2, D1, D8
• DDP
75 mg/m2, D1

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression Free Survival (PFS)		6 weeks
Secondary	Objective Response Rate (ORR)		6 weeks
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		6 weeks
Secondary	Overall Survival (OS)		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months