Clinical trial NCT02687490: Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer
Official title: A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 81
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Abraxane in patients with visceral metastases dominant metastatic breast cancer

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

Eligibility 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: 8 weeks
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 8 weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 8 weeks
measure: Overall Survival (OS)
timeFrame: 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
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
Study officials:
affiliation: Fudan University
name: Xichun Hu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xie Y, Gong C, Zhang J, Wang L, Cao J, Tao Z, Li T, Zhao Y, Li Y, Hu S, Wang B, Hu X. Phase II trail of nab-paclitaxel in metastatic breast cancer patients with visceral metastases. BMC Cancer. 2021 Nov 2;21(1):1174. doi: 10.1186/s12885-021-08921-2.