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Apatinib Combined with Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer

ConditionAdvanced Triple Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFujian Cancer Hospital

About this trial

This study is a single-arm,exploratory clinical study, to evaluate the effectiveness and safety of apatinib mesylate combined with albumin-bound paclitaxel for second-line treatment of advanced triple negative breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary tumor stage determined by standard evaluation methods: CT0-4 /N0-3/M1;

Pathologically confirmed breast cancer with negative HER2 expression, defined as < 10% immunoreactive cells with an IHC score of + or -,or in situ hybridization (ISH) resulting in no HER2 gene amplification (RATIO of HER2 gene signal to centromeric 17 signal < 2.0 and HER2 gene copy number/cell < 4.0);

Negative hormone receptor status (ER and PgR) is known, which is defined as < 1% detected by immunohistochemistry;

A previous systemic therapy, including anthracyclines, for recurrence/metastasis.

Disqualifiers

1.Pregnant or lactating women. 2.Previous or coexisting malignancies, unless they are basal cell carcinoma of the skin, superficial bladder carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other cancers in situ that have achieved complete remission at least 5 years prior to screening and that do not require or are expected to require additional treatment during the study.

Trial design

Design model

Single group

Treatments tested in this trial

  • Apatinib Mesylate

    Drug

    Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet,QD,Q3W

  • Albumin-Bound Paclitaxel

    Drug

    Subjects receive Albumin-Bound Paclitaxel,ivgtt, Strength: 125 mg/m\^2,d1、7、15,Q3W

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: Apatinib Combined With Albumin-Bound PaclitaxelExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-Free Survival(PFS)

PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. The PFS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median PFS, hazard ratio with appropriate confidence intervals will be reported.

Time frame
From enrollment to 12 month

Secondary outcomes

1

Overall Survival (OS)

Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization. The OS will be will be estimated using Kaplan-Meier method. A Kaplan-Meier curve, median OS, hazard ratio with appropriate confidence intervals will be reported.

Time frame
From enrollment to 24 month
2

Objective response rate(ORR)

ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable. The ORR will be reported by percentage with each arms and appropriate confidence intervals.

Time frame
From enrollment to 12 month
3

Disease control rate(DCR)

DCR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR or SD. DCR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR or SD to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable. The DCR will be reported by percentage with each arms and appropriate confidence intervals. \[Time Frame: From enrollment to 12 month\]

Time frame
From enrollment to 12 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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