Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer

NCT02687490 | Completed Phase 2

• 1 other identifier: Fudan BR2016-20
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

Abraxane in patients with visceral metastases dominant metastatic breast cancer

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  8 weeks

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  8 weeks

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  8 weeks

• 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

Study Arms (1)

Abraxane

EXPERIMENTAL

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

Drug: Abraxane

Interventions

Abraxane DRUG

125 mg/m2, D1, D8, D15

Abraxane

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed metastatic breast cancer;
• Radiologically or histologically confirmed visceral dominant metastases;
• 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;
• At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1);
• 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;
• Eastern Cooperative Oncology Group performance (ECOG) status of 0-1;
• All patients enrolled are required to have adequate hematologic, hepatic, and renal function;
• Life expectancy longer than 12 weeks;
• No medical history of serious cardiovascular, hepatic, respiratory or renal diseases;
• Informed consent;
• Patients with good compliance.

You may not qualify if:

• Pregnant, lactating women or women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study;
• Patients who are expected to acquire benefit from endocrine or target therapy;
• Radiotherapy of axial bones within 4 weeks before enrollment or lack of recovery from prior radiotherapy;
• Treatment with other experimental drug within 4 weeks before enrollment;
• 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;
• 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;
• Patients with a history of symptomatic cardiovascular, hepatic, respiratory, renal , hematological, endocrinal, neurological or psychiatric diseases;
• Uncontrolled serious infection.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

Related Publications (1)

• 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.

  PMID: 34727875 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Xichun Hu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of department of medical oncology

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: February 22, 2016
• Study Start: February 24, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 15, 2020
• Last Updated: March 1, 2021

Record last verified: 2021-02

Locations

CN (1)