Phase Ib/II Study of LY2780301 in Combination With Weekly PACLITAXEL in HER2-metastatic Breast Cancer (TAKTIC)
A Prospective, Multicentre, Uncontrolled, Phase Ib/II Study of LY2780301 in Combination With Weekly Paclitaxel in HER2-negative Metastatic or Locally Advanced Breast Cancer in Patients With and Without PI3/AKT/S6 Pathway Activation. - TAKTIC-IPC 2012-008
Sponsor: Institut Paoli-Calmettes
Terminated
Drug development stopped
Other terminated trials from Institut Paoli-Calmettes
A observational or N/A phase clinical study on Breast Cancer, this trial is terminated or withdrawn. The trial is conducted by Institut Paoli-Calmettes and has accumulated 9 data snapshots since 2014. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Study Description(click to expand)RATIONALE OF THE STUDY DESIGN
The purpose of this study will be:
1. to determine the recommended phase 2 dose (RP2D) for LY2780301 in combination with weekly paclitaxel in HER2-negative, inoperable locally advanced or MBC patients
2. to estimate the objective response rate (ORR) of the combination in first-line treated, HER2-negative, inoperable locally advanced or MBC patients. In addition, this study will assess the role of PI3K/AKT/S6 pathway activation as potential predictive factor for response to LY2780301 in this patient population.
This trial will be a phase Ib/II prospective, multicentre, open label, uncontrolled study.
Phase Ib will use a continuous reassessment method (CRM) design, allowing to reach safely and quickly the MTD and the RP2D of the combination, but ensuring the treatment of at least 18 patients to secure the tolerance profile.
Phase II will estimate antitumor activity in the overall patient population and in patients with activation of PI3K/AKT/S6 axis, allowing to examine its potential value as predictive biomarker
RATIONALE OF THE STUDY DESIGN
The purpose of this study will be:
1. to determine the recommended phase 2 dose (RP2D) for LY2780301 in combination with weekly paclitaxel in HER2-negative, inoperable locally advanced or MBC patients 2. to estimate the objective response rate (ORR) of the combination in first-line treated, HER2-negative, inoperable locally advanced or MBC patients. In addition, this study will assess the role of PI3K/AKT/S6 pathway activation as potential predictive factor for response to LY2780301 in this patient population.
This trial will be a phase Ib/II prospective, multicentre, open label, uncontrolled study.
Phase Ib will use a continuous reassessment method (CRM) design, allowing to reach safely and quickly the MTD and the RP2D of the combination, but ensuring the treatment of at least 18 patients to secure the tolerance profile.
Phase II will estimate antitumor activity in the overall patient population and in patients with activation of PI3K/AKT/S6 axis, allowing to examine its potential value as predictive biomarker
Status Flow
Change History
9 versions recorded-
Apr 21, 2026 — Present [daily]
Terminated
Phase: PHASE1/PHASE2 → None
-
Sep 2024 — Apr 2026 [monthly]
Terminated PHASE1/PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Terminated PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Jan 2021 — Jul 2024 [monthly]
Terminated PHASE1_PHASE2
-
Feb 2019 — Jan 2021 [monthly]
Terminated PHASE1_PHASE2
Status: Active Not Recruiting → Terminated
▶ Show 4 earlier versions
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Jul 2018 — Feb 2019 [monthly]
Active Not Recruiting PHASE1_PHASE2
Status: Recruiting → Active Not Recruiting
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Jun 2018 — Jul 2018 [monthly]
Recruiting PHASE1_PHASE2
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Oct 2017 — Jun 2018 [monthly]
Recruiting PHASE1_PHASE2
-
Jan 2017 — Oct 2017 [monthly]
Recruiting PHASE1_PHASE2
First recorded
Jan 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
The overall rationale of this study evaluating tolerance and efficacy of LY2780301 in combination with paclitaxel in HER2-negative, inoperable locally advanced or metastatic breast cancer (MBC) is based on : * the medical need in this population with either hormonal-resistant or unsensitive and/or rapidly progressive disease * the preclinical evidences for involvement of PI3K/AKT pathway in tumor progression and drug resistance, including taxanes as well as its potential reversion by AKT inhibition * the high level of frequency of PI3K/AKT activation in HER2-negative MBC * the in vitro and in vivo preclinical activity of LY2780301, and its synergistic combination with various anticancer agents, including taxanes * the favourable profile of tolerance of LY2780301 in phase I trial Weekly paclitaxel is conventionally administered at 80 mg/m²/week and is a standard treatment in breast cancer (BC) As described above, LY2780301 500 mg once daily has been established as the RP2D in phase I single agent trial. Evidence of pharmacodynamic activity was noted at 400-500 mg QD. Conservatively, the first dose level to be explored will be LY2780301 400 mg QD and paclitaxel 70 mg/m²/week.
Contact Information
- Institut Paoli-Calmettes
For direct contact, visit the study record on ClinicalTrials.gov .