FUSCC Refractory TNBC Umbrella (FUTURE)

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a Phase Ib/II, open-label, umbrella study evaluating the efficacy and safety of multiple targeted treatment in patients with refractory metastatic TNBC.The specific grouping of patients' depends on FUSCC 500+ gene panel testing and IHC subtype staining.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Albumin-Bound Paclitaxel; Androgen Receptor Antagonists; Apatinib; Capecitabine; Everolimus; Paclitaxel; Poly(ADP-ribose) Polymerase Inhibitors; Sirolimus

Criteria

Inclusion Criteria:

• ECOG Performance Status of 0, 1, or 2

• Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)

• Radiologic/objective evidence of recurrence or disease progression after available standard chemotherapy regimens(anthracyclines,taxanes, platinums, vinorelbine,capacitabine, and gemcitabine included) for metastatic breast cancer(MBC)

• Availability of a representative tumor specimen that is suitable for rebiopsy, IHC staining and gene sequencing

• Adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment.

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm

• Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)

• 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

• Active or history of autoimmune disease or immune deficiency

• Significant cardiovascular disease

• History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death

• Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded)within3 weeks prior to initiation of study treatment.

• Pregnancy or breastfeeding, or intention of becoming pregnant during the study