Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-24

Study Completion Date

2020-12-15

Brief Summary

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Abraxane in patients with visceral metastases dominant metastatic breast cancer

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Detailed Description

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

Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Abraxane

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

Group Type EXPERIMENTAL

Abraxane

Intervention Type DRUG

125 mg/m2, D1, D8, D15

Interventions

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Abraxane

125 mg/m2, D1, D8, D15

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No