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Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02687490
Recruitment Status : Recruiting
First Posted : February 22, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Xichun Hu, Fudan University

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

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Abraxane Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 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 : February 24, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Abraxane
Abraxane: 125 mg/m2, D1, D8, D15 every 28 days
Drug: Abraxane
125 mg/m2, D1, D8, D15




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: 8 weeks ]
  2. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 8 weeks ]
  3. Overall Survival (OS) [ Time Frame: 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02687490


Contacts
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Contact: Xichun Hu, MD, PhD 64175590 ext 85006 huxicun@gmail.com
Contact: Biyun Wang, MD 64175590 ext 85000 pro_wangbiyun@163.com

Locations
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China
Fudan University Cancer Hospital Recruiting
Shanghai, China, 200032
Contact: Xichun Hu, MD,PhD    64175590 ext 85006    huxicun@gmail.com   
Contact: Biyun Wang, MD    64175590 ext 85000    pro_wangbiyun@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Xichun Hu, MD, PhD Fudan University

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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: February 22, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents