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Trial Title:
Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer
NCT ID:
NCT05806060
Condition:
Triple-Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Vinorelbine
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Capecitabine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine
Description:
VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as
a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed
with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and
bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks.
Arm group label:
De novo or DFI≥12m Arm 1
Other name:
Bevacizumab (BP102)
Intervention type:
Drug
Intervention name:
nab-paclitaxel, with maintenance of capecitabine
Description:
Nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if
intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2
po bid d1-d14 every 3 weeks.
Arm group label:
De novo or DFI≥12m Arm 2
Intervention type:
Drug
Intervention name:
Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1
Description:
TPC
Arm group label:
DFI<12m Arm 2
Intervention type:
Drug
Intervention name:
VEGFR and TPC
Description:
VEGFR bevacizumab and TPC
Arm group label:
DFI<12m Arm 1
Other name:
Bevacizumab (BP102)
Summary:
The study is being conducted to evaluate VEGFR BP102 with nab-paclitaxe or treatment of
physician's choice (TPC) versus nab-paclitaxe or TPC in patients for basal-like immune
suppressed (BLIS) subtype of triple-negative breast cancer (TNBC) in the first-line
teatment of unresectable locally advanced or metastatic TNBC.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- ECOG Performance Status of 0-1
- Expected lifetime of not less than three months
- Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER,
and PR expression) with BLIS subtype
- Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed
by the researchers could not be radical resection
- Patients had received no previous chemotherapy or targeted therapy for metastatic
triple-negative breast cancer
- At least one measurable or non-measurable lesion according to Response Evaluation
Criteria in Solid Tumors v1.1 (RECIST v1.1), which didn't receive radiation therapy
- The functions of major organs are basically normal
- For women of childbearing potential: agreement to remain abstinent (refrain from
heterosexual intercourse) or use contraceptive measures as outlined for each
specific treatment arm
- Have the cognitive ability to understand the protocol and be willing to participate
and to be followed up
Exclusion Criteria:
- Symptomatic, untreated, or actively progressing CNS metastases
- Significant cardiovascular disease
- Adverse reactions of Grade ≥1 that are still continuing due to previous treatments.
Exceptions are those of hair loss or which researchers take it as exception
- Major surgery was performed within 3 weeks of the first course of trial treatment
(except for minor outpatient surgery, such as placement of vascular access)
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Other malignancies within 5 years, excluding cured cervical carcinoma in situ, skin
basal cell carcinoma, or skin squamous cell carcinoma
- Inability to swallow, chronic diarrhea and intestinal obstruction, there are
multiple factors that affect the use and absorption of drugs
- Presence of third-space fluid accumulation that cannot be controlled by drainage or
other methods (such as excessive pleural fluid and ascites)
- Participated in clinical trials of other antitumor drugs within 4 weeks before first
taking the investigational drug
- Long-term unhealing wound or incomplete healing of fracture
- Patients with known active HBV or HCV infection or hepatitis B DNA≥500, or chronic
phase with abnormal liver function
- Allergic constitution, or known allergic history of the drug components of this
trial; Or allergic to other monoclonal antibodies
- Patients with a history of gastrointestinal bleeding or a clear tendency to
gastrointestinal bleeding within the past 6 months, such as esophageal varicose
veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++),
were not allowed to enter the group; If there is occult blood in the stool (+),
gastroscopy is required
- Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within
28 days before participating in this trial
- Urine protein ≥2+ and 24h urine protein quantitative > 1.0 g
- Patients suffering from hypertension and unable to reach the normal range after
antihypertensive drug treatment (systolic blood pressure >140mmHg, diastolic blood
pressure >90mmHg)
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast cancer institute of Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhi-Ming Shao, MD
Phone:
86-21-641755901105
Email:
zhimingshao@yahoo.com
Contact backup:
Last name:
Lei Fan, MD
Phone:
86-21-641755901105
Email:
cmchen@medmail.com.cn
Investigator:
Last name:
Zhi-Ming Shao, MD
Email:
Principal Investigator
Investigator:
Last name:
Min He, MD
Email:
Sub-Investigator
Investigator:
Last name:
Linxiaoxi Ma, MD
Email:
Sub-Investigator
Investigator:
Last name:
Ying Zhou
Email:
Sub-Investigator
Start date:
April 25, 2023
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05806060
