Overview

Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer

Status:
Completed
Trial end date:
2020-12-15
Target enrollment:
0
Participant gender:
Female
Summary
Abraxane in patients with visceral metastases dominant metastatic breast cancer
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Albumin-Bound Paclitaxel
Paclitaxel
Criteria
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.