Evidence map›Paper›PMID 30185228›Full record

ArticleBreast cancer research : BCR2018

A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer.

Patrick Schöffski, Sara Cresta, Ingrid A Mayer, Hans Wildiers, Silvia Damian, Steven Gendreau, Isabelle Rooney, Kari M Morrissey, Jill M Spoerke, Vivian W Ng and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Breast cancer research : BCR, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00960960 (A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of PI3-Kinase Inhibitor GDC-0941), which is not on this map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
2.5field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00960960 phase1completednot on this map

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of PI3-Kinase Inhibitor GDC-0941 (Pictilisib) in Combination With Paclitaxel, With and Without Bevacizumab or Trastuzumab, and With Letrozole in Patients With Locally Recurrent Or Metastatic Breast Cancer

TypeinterventionalSponsorGenentech, Inc.Ran2009 to 2015Enrolled71ConditionsBreast CancerArmsBevacizumab, Pictilisib, Letrozole, Paclitaxel, Trastuzumab
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 93 citations in OpenAlex.

  1. Review
  2. Targeting the PI3K/AKT/mTOR signaling pathway in prostate cancer: Molecular dysregulation, therapeutic advances, and future directions.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2026
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  5. Advancing influenza virus treatment:Materials today. Bio · 2025
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  16. Regulation of PI3K signaling in cancer metabolism and PI3K-targeting therapy.Translational breast cancer research : a journal focusing on translational research in breast cancer · 2024
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 4 institutions in 3 countries.

Patrick SchöffskiDepartment of General Medical Oncology, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium. patrick.schoffski@uzleuven.be.
Sara CrestaDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Ingrid A MayerDepartment of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Hans WildiersDepartment of General Medical Oncology, Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium.
Silvia DamianDepartment of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
Steven GendreauOncology Biomarker Development, Genentech Inc, South San Francisco, CA, USA.
Isabelle RooneyProduct Development Oncology, Genentech Inc, South San Francisco, CA, USA.
Kari M MorrisseyClinical Pharmacology, Genentech Inc, South San Francisco, CA, USA.
Jill M SpoerkeOncology Biomarker Development, Genentech Inc, South San Francisco, CA, USA.
Vivian W NgBiostatistics, Genentech Inc, South San Francisco, CA, USA.
Stina M SingelProduct Development Oncology, Genentech Inc, South San Francisco, CA, USA.
Eric WinerDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.
Fondazione IRCCS Istituto Nazionale dei Tumori · ITKU Leuven · BEDana-Farber Cancer Institute · USVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis phase Ib study (NCT00960960) evaluated pictilisib (GDC-0941; pan-phosphatidylinositol 3-kinase inhibitor) plus paclitaxel, with and without bevacizumab or trastuzumab, or in combination with letrozole, in patients with locally recurrent or metastatic breast cancer.

methodsThis was a three-part multischedule study. Patients in parts 1 and 2, which comprised 3 + 3 dose escalation and cohort expansion stages, received pictilisib (60-330 mg) plus paclitaxel (90 mg/m

resultsSixty-nine patients were enrolled; all experienced at least one adverse event (AE). Grade ≥ 3 AEs, serious AEs, and AEs leading to death were reported in 50 (72.5%), 21 (30.4%), and 2 (2.9%) patients, respectively. Six (8.7%) patients reported a DLT, and the MTD and recommended phase II pictilisib doses were established where possible. There was no pictilisib-paclitaxel drug-drug interaction. Two (3.4%) patients experienced complete responses, and 17 (29.3%) patients had partial responses.

conclusionsCombining pictilisib with paclitaxel, with and without bevacizumab or trastuzumab, or letrozole, had a manageable safety profile in patients with locally recurrent or metastatic breast cancer. The combination had antitumor activity, and the additive effect of pictilisib supported further investigation in a randomized study.

trial registrationClinicalTrials.gov, NCT00960960 . Registered on August 13, 2009.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBreast NeoplasmsCohort StudiesDiarrheaDose-Response Relationship, DrugFemaleHumansIndazolesLetrozoleMiddle AgedNauseaPaclitaxelSulfonamides2-(1H-indazol-4-yl)-6-(4-methanesulfonylpiperazin-1-ylmethyl)-4-morpholin-4-ylthieno(3,2-d)pyrimidineBevacizumabIndazolesLetrozolePaclitaxelSulfonamidesTrastuzumabGDC-0941PI3KPictilisib

Identifiers

PMID30185228
PMCPMC6125885
OpenAlexW2890142259

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.