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Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer

Sponsor
Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT02687490
Collaborator
(none)
81
Enrollment
1
Location
1
Arm
45.7
Actual Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Abraxane in patients with visceral metastases dominant metastatic breast cancer

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
81 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer
Actual Study Start Date :
Feb 24, 2017
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Abraxane

Abraxane: 125 mg/m2, D1, D8, D15 every 28 days

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

Outcome Measures

Primary Outcome Measures

  1. Progression Free Survival (PFS) [8 weeks]

Secondary Outcome Measures

  1. Objective Response Rate (ORR) [8 weeks]

  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [8 weeks]

  3. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fudan University Cancer Hospital Shanghai China 200032

Sponsors and Collaborators

  • Fudan University

Investigators

  • Principal Investigator: Xichun Hu, MD, PhD, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xichun Hu, Vice Director of department of medical oncology, Fudan University
ClinicalTrials.gov Identifier:
NCT02687490
Other Study ID Numbers:
  • Fudan BR2016-20
First Posted:
Feb 22, 2016
Last Update Posted:
Mar 1, 2021
Last Verified:
Feb 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms
Albumin-Bound Paclitaxel

Study Results

No Results Posted as of Mar 1, 2021