Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02687490
• Other study ID #: Fudan BR2016-20
• Status: Completed
• Phase: Phase 2
• Start date: February 24, 2017
• Est. completion date: December 15, 2020

Study information

• Verified date: February 2021
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Abraxane in patients with visceral metastases dominant metastatic breast cancer

Description:

A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in patients with visceral metastases dominant metastatic breast cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 15, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Histologically confirmed metastatic breast cancer;

2. Radiologically or histologically confirmed visceral dominant metastases;

3. Patients who are expected to acquire benefit from chemotherapy: ER and/or PR positive patients who developed resistance after prior endocrine therapy; HER2+ patients who experienced disease progression on prior target therapy and are not suitable for subsequent target therapy; mTNBC patients who relapsed after platinum therapy;

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

5. Patients who received paclitaxol in metastatic setting should be proven effective to prior paclitaxol based regimen and disease progressed after at least 3 months from the last administration of paclitaxol; those who received paclitaxel as neoadjuvant/adjuvant therapy can be enrolled if disease relapsed after at least 6 months from the completion of neoadjuvant/adjuvant chemotherapy. Patients who received docetaxol have no limitation for enrollment;

6. Eastern Cooperative Oncology Group performance (ECOG) status of 0-1;

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

8. Life expectancy longer than 12 weeks;

9. No medical history of serious cardiovascular, hepatic, respiratory or renal diseases;

10. Informed consent;

11. Patients with good compliance.

Exclusion Criteria:

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

2. Patients who are expected to acquire benefit from endocrine or target therapy;

3. Radiotherapy of axial bones within 4 weeks before enrollment or lack of recovery from prior radiotherapy;

4. Treatment with other experimental drug within 4 weeks before enrollment;

5. 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 enrollment;

6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia;

7. Patients with a history of symptomatic cardiovascular, hepatic, respiratory, renal , hematological, endocrinal, neurological or psychiatric diseases;

8. Uncontrolled serious infection.

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Abraxane
125 mg/m2, D1, D8, D15

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)		8 weeks
Secondary	Objective Response Rate (ORR)		8 weeks
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		8 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