Apatinib Combined with Albumin-Bound Paclitaxel for Treatment of Advanced 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
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
Treatments tested in this trial
- Apatinib Mesylate
- Albumin-Bound Paclitaxel
Treatment groups
29 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov