Breast CancerPhase 1/2TAKTICNCT01980277

Phase Ib/II Study of LY2780301 in Combination With Weekly PACLITAXEL in HER2-metastatic Breast Cancer

A Phase 1/2 study testing LY2780301 + paclitaxel in people with Breast Cancer, run by Institut Paoli-Calmettes at 2 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer
What is being tested?: LY2780301 + paclitaxel
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 2 sitesFrance
Study dates: Jan 2014to 12 Dec 2018
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female or male patients (≥ 18 years)
WHO/ECOG performance status ≤ 1 for phase Ib part, < 2 for phase II part
Patient with histologically confirmed inoperable locally advanced BC or MBC
Patient with tumor biopsy from metastatic tissue containing more than 50% tumor cells
Patient has known hormone receptor (ER/PR) status, positive and/or negative (local laboratory testing)
Patient has HER2-negative disease: IHC 0, 1 + or 2+ and/or in situ hybridization (FISH, CISH, SISH) negative (local laboratory testing)

Show all 14Show fewer

Phase Ib: Patient has measurable or non-measurable disease according to RECIST 1.1 criteria only Phase II: Patient has measurable disease according to RECIST 1.1 criteria only
Patient has adequate bone marrow and organ function
Patient is able to swallow and retain oral medication
Negative serum pregnancy test within ≤ one week before first dose for childbearing potential women and for women < 12 months after the onset of menopause
Males and Females of childbearing potential (FCBP) must agree to use a reliable form of contraception or to practice complete abstinence from heterosexual intercourse during the study treatment (and 3 months after the end of treatment)
Life expectancy > 3 months
Affiliation to social security or beneficiary
Patient has signed the Informed Consent (ICF) prior to any screening procedures being performed

Who cannot join

Previous treatment with AKT or PI3K inhibitor
no previous cytotoxic treatment for metastatic or inoperable locally advanced disease (phase II part); Adjuvant/neoadjuvant therapy will be counted as prior line of therapy for metastatic/recurrent disease if the patient had a progression/recurrence within 6 months after completion of the therapy (12 months for taxane-based therapy). Previous hormonal treatment for metastatic or locally advanced disease is allowed.
Patient with bone metastases only
Patient has symptomatic CNS metastases; patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior local treatment for CNS metastases ≥ 15 days prior to the start of study treatment (including radiotherapy and/or surgery) and must have completed corticosteroid therapy.
Patient has a concurrent malignancy or malignancy within 3 years of study enrollment
Patient has received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study

Show all 24Show fewer

Patients who have received chemotherapy or targeted anticancer therapy ≤ 4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C; 3 weeks for weekly chemotherapy) prior to starting study drug or who have not recovered from side effects of such therapy
Patients who have received any continuous or intermittent small molecule therapeutics (excluding monoclonal antibodies) ≤ 5 effective half-lives prior to starting study drug or who have not recovered from side effects of such therapy
Patients who have undergone major surgery ≤ 28 days prior to starting study drug or who have not recovered from side effects of such therapy
Known diagnosis of human immunodeficiency virus (HIV) infection
Patient has a known hypersensitivity to paclitaxel or other products containing Cremophor
Patient has a contraindication to use the paclitaxel standard pre-treatment such as corticosteroids
Patients with any peripheral neuropathy ≥ CTCAE grade 2
Patients with diarrhea ≥ CTCAE grade 2
Patient has active cardiac disease
Patient has a history of cardiac dysfunction including
Patients who are currently receiving treatment with medication with a known risk prolong the QT interval or inducing Torsades de Pointes
Patient has poorly controlled diabetes mellitus (HbA1c > 8 %)
Other concurrent severe and/or uncontrolled concomitant medical conditions
Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of LY2780301
Patient is currently receiving treatment with drugs known to be substrate of isoenzyme CYP3A4
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
Patient who does not apply effective contraception during the study and through the duration as defined below after the final dose of study treatment.
Other experimental treatment

Trial locations and contacts

2 sites in 1 country.

France2 sites

Centre Geroges François Leclerd
Dijon, 21079
Institut Paoli-Calmettes
Marseille, 13008

Other trials in France

About this study

Official title: 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

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.

Read the detailed description

RATIONALE OF THE STUDY DESIGN

The purpose of this study will be:

to determine the recommended phase 2 dose (RP2D) for LY2780301 in combination with weekly paclitaxel in HER2-negative, inoperable locally advanced or MBC patients
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

Conditions: Breast Cancer
Being tested: LY2780301 + paclitaxel
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY2780301 + paclitaxelDrug
Continuous daily PO LY2780301 (400 mg, 500 mg or 300 mg) QD + weekly paclitaxel (70 or 80 mg/m²/week) for 21 days cycle until progression or toxicity

Study groups in NCT01980277
Study group	Role	What they receive
LY2780301 + paclitaxel	Experimental	The following dose-levels will be investigated: * Continuous daily PO LY2780301 400 mg QD + weekly paclitaxel 70 mg/m²/week * Continuous daily PO LY2780301 400 mg QD + weekly paclitaxel 80 mg/m²/week * Continuous daily PO LY2780301 500 mg QD + weekly paclitaxel 80 mg/m²/week A dose reduction could be explored: - Continuous daily PO LY2780301 300 mg QD + weekly paclitaxel 70 mg/m²/week Receives: Drug: LY2780301 + paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase Ib: recommended phase II dose (RP2D)
To determine the recommended phase II dose (RP2D) of daily LY2780301 when administered orally in combination with weekly intravenous (IV) paclitaxel in HER2-negative, inoperable locally advanced or MBC patients
Measured: Day 28
Phase II: objective response rate (ORR)
To estimate the efficacy of daily LY2780301 when administered orally at the RP2D in combination with weekly intravenous (IV) paclitaxel in HER2-negative, inoperable locally advanced or MBC patients, in the overall population and in patients with activation of PI3/AKT/S6 pathway
Measured: until progression assessed up to 18 months

Secondary outcomes (4)

safety
Type and severity of adverse events according to CTCAE v4.0 up to the end of treatment or maximum 6 months
Measured: up to the end of treatment or maximum 6 months
clinical benefit (CB)
The Clinical benefit (CB) is defined as the addition of complete response (CR) + partial response (PR) + Stable disease (SD) > 6 months
Measured: until progression assessed up to 18 months
progression-free survival (PFS)
Date of progression (evaluated according to RECIST V1.1 criteria) or death up to 18 months
Measured: until progression assessed up to 18 months
pharmacokinetics
Pharmacokinetics of LY2780301 and paclitaxel evaluated by plasma concentrations and basic PK parameters
Measured: D1, D8, D15, D22, D28 post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201412 Dec 2018

First posted8 Nov 2013 (estimated)
Study startJan 2014
Primary completionMay 2017
Study completion12 Dec 2018

Why it stopped: Drug development stopped

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 68 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01980277
Sponsor's protocol ID: TAKTIC - IPC 2012-008
Acronym: TAKTIC
Status last verified: Jan 2019
First submitted: 4 Nov 2013
Last updated: 21 Apr 2026
Results posted: No
Data monitoring committee: Yes

Publications

Vicier C, Sfumato P, Isambert N, Dalenc F, Robert M, Levy C, Rezai K, Provansal M, Adelaide J, Garnier S, Guille A, Carbuccia N, Popovici C, Charafe-Jauffret E, Chaffanet M, Birnbaum D, Pakradouni J, Bertucci F, Boher JM, Sabatier R, Goncalves A. TAKTIC: A prospective, multicentre, uncontrolled, phase IB/II study of LY2780301, a p70S6K/AKT inhibitor, in combination with weekly paclitaxel in HER2-negative advanced breast cancer patients. Eur J Cancer. 2021 Dec;159:205-214. doi: 10.1016/j.ejca.2021.09.040. Epub 2021 Nov 12.
PubMed 34781168
Sabatier R, Vicier C, Garnier S, Guille A, Carbuccia N, Isambert N, Dalenc F, Robert M, Levy C, Pakradouni J, Adelaide J, Chaffanet M, Sfumato P, Mamessier E, Bertucci F, Goncalves A. Circulating tumor DNA predicts efficacy of a dual AKT/p70S6K inhibitor (LY2780301) plus paclitaxel in metastatic breast cancer: plasma analysis of the TAKTIC phase IB/II study. Mol Oncol. 2022 May;16(10):2057-2070. doi: 10.1002/1878-0261.13188. Epub 2022 Mar 30.
PubMed 35122700

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01980277
Acronym / sponsor ID: TAKTIC / TAKTIC - IPC 2012-008
Conditions: Breast Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Drug development stopped
Enrolment: 68 participants (estimated)
Lead sponsor: Institut Paoli-CalmettesUniversity, hospital or other
Study start: Jan 2014 (actual)
Primary completion: May 2017 (actual)
Study completion: 12 Dec 2018 (actual)
First posted: 8 Nov 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Detailed description

RATIONALE OF THE STUDY DESIGN

The purpose of this study will be:

to determine the recommended phase 2 dose (RP2D) for LY2780301 in combination with weekly paclitaxel in HER2-negative, inoperable locally advanced or MBC patients
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 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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LY2780301 + paclitaxel	Experimental	Drug: LY2780301 + paclitaxelThe following dose-levels will be investigated: * Continuous daily PO LY2780301 400 mg QD + weekly paclitaxel 70 mg/m²/week * Continuous daily PO LY2780301 400 mg QD + weekly paclitaxel 80 mg/m²/week * Continuous daily PO LY2780301 500 mg QD + weekly paclitaxel 80 mg/m²/week A dose reduction could be explored: - Continuous daily PO LY2780301 300 mg QD + weekly paclitaxel 70 mg/m²/week

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Female or male patients (≥ 18 years)
WHO/ECOG performance status ≤ 1 for phase Ib part, < 2 for phase II part
Patient with histologically confirmed inoperable locally advanced BC or MBC
Patient with tumor biopsy from metastatic tissue containing more than 50% tumor cells
Patient has known hormone receptor (ER/PR) status, positive and/or negative (local laboratory testing)

Key exclusion criteria (24 listed)

Previous treatment with AKT or PI3K inhibitor
no previous cytotoxic treatment for metastatic or inoperable locally advanced disease (phase II part); Adjuvant/neoadjuvant therapy will be counted as prior line of therapy for metastatic/recurrent disease if the patient had a progression/recurrence within 6 months after completion of the therapy (12 months for taxane-based therapy). Previous hormonal treatment for metastatic or locally advanced disease is allowed.
Patient with bone metastases only
Patient has symptomatic CNS metastases; patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior local treatment for CNS metastases ≥ 15 days prior to the start of study treatment (including radiotherapy and/or surgery) and must have completed corticosteroid therapy.
Patient has a concurrent malignancy or malignancy within 3 years of study enrollment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY2780301 + paclitaxelContinuous daily PO LY2780301 (400 mg, 500 mg or 300 mg) QD + weekly paclitaxel (70 or 80 mg/m²/week) for 21 days cycle until progression or toxicity	Drug	LY2780301 + paclitaxel

Primary outcome

Phase Ib: recommended phase II dose (RP2D)
Time frame: Day 28
To determine the recommended phase II dose (RP2D) of daily LY2780301 when administered orally in combination with weekly intravenous (IV) paclitaxel in HER2-negative, inoperable locally advanced or MBC patients
Phase II: objective response rate (ORR)
Time frame: until progression assessed up to 18 months
To estimate the efficacy of daily LY2780301 when administered orally at the RP2D in combination with weekly intravenous (IV) paclitaxel in HER2-negative, inoperable locally advanced or MBC patients, in the overall population and in patients with activation of PI3/AKT/S6 pathway

4 secondary outcomes

safety
Time frame: up to the end of treatment or maximum 6 months
clinical benefit (CB)
Time frame: until progression assessed up to 18 months
progression-free survival (PFS)
Time frame: until progression assessed up to 18 months
pharmacokinetics
Time frame: D1, D8, D15, D22, D28 post dose

Results and safety

The study was stopped early (reason given: Drug development stopped). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Results publication: PubMed 34781168Vicier C, Sfumato P, Isambert N, Dalenc F, Robert M, Levy C, Rezai K, Provansal M, Adelaide J, Garnier S, Guille A, Carbuccia N, Popovici C, Charafe-Jauffret E, Chaffanet M, Birnbaum D, Pakradouni J, Bertucci F, Boher JM, Sabatier R, Goncalves A. TAKTIC: A prospective, multicentre, uncontrolled, phase IB/II study of LY2780301, a p70S6K/AKT inhibitor, in combination with weekly paclitaxel in HER2-negative advanced breast cancer patients. Eur J Cancer. 2021 Dec;159:205-214. doi: 10.1016/j.ejca.2021.09.040. Epub 2021 Nov 12.
Results publication: PubMed 35122700Sabatier R, Vicier C, Garnier S, Guille A, Carbuccia N, Isambert N, Dalenc F, Robert M, Levy C, Pakradouni J, Adelaide J, Chaffanet M, Sfumato P, Mamessier E, Bertucci F, Goncalves A. Circulating tumor DNA predicts efficacy of a dual AKT/p70S6K inhibitor (LY2780301) plus paclitaxel in metastatic breast cancer: plasma analysis of the TAKTIC phase IB/II study. Mol Oncol. 2022 May;16(10):2057-2070. doi: 10.1002/1878-0261.13188. Epub 2022 Mar 30.
official web site of the sponsorLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anthony GONCALVES, MD principal investigator

Institut Paoli-Calmettes

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LY2780301 + paclitaxel in people with Breast Cancer, run by Institut Paoli-Calmettes at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Drug development stopped). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase Ib: recommended phase II dose (RP2D) (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01980277, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.