A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer

Recruiting in Palo Alto (17 mi)

+44 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in women with triple negative breast cancer whose tumors are positive for a defined pattern of gene expression

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

Histologically confirmed diagnosis of invasive triple negative breast cancer

Known status for the LCL161 predictive gene expression signature as determined during molecular pre-screening

Candidates for mastectomy or breast-conserving surgery

See 7 more

Treatment Details

Interventions

LCL161 (Smac Mimetic)
Paclitaxel (Taxane)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Paclitaxel with LCL161Experimental Treatment2 Interventions

Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.

Group II: Paclitaxel without LCL161Active Control1 Intervention

Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.

Paclitaxel is already approved in Canada for the following indications: