Evidence map›Paper›PMID 19047121›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2008

Phase I/II study of G3139 (Bcl-2 antisense oligonucleotide) in combination with doxorubicin and docetaxel in breast cancer.

Stacy L Moulder, W Fraser Symmans, Daniel J Booser, Timothy L Madden, Cindy Lipsanen, Linda Yuan, Abenaa M Brewster, Massimo Cristofanilli, Kelly K Hunt, Thomas A Buchholz and 4 more

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 58 citations in OpenAlex.

  1. Are RNA Therapies a Solid Foundation or a Frontier Yet to Be Conquered?International journal of molecular sciences · 2026
    Review
  2. Article
  3. Review
  4. Non-Coding RNA-Targeted Therapy: A State-of-the-Art Review.International journal of molecular sciences · 2024
    Review
  5. Article
  6. Noncoding RNA therapeutics for substance use disorder.Advances in drug and alcohol research · 2022
    Article
  7. A Brief Introduction to Current Cancer Gene Therapy.Methods in molecular biology (Clifton, N.J.) · 2022
    Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Article
  15. BCL2 is an independent predictor of outcome in basal-like triple-negative breast cancers treated with adjuvant anthracycline-based chemotherapy.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2015
    Article
  16. Article
  17. Article
  18. Article
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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

14 authors at 2 institutions in 1 country.

Stacy L MoulderDepartment of Breast Medical Oncology, Pathology, Surgical Oncology, Radiation Oncology and Experimental Therapeutics, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA.
W Fraser Symmans
Daniel J Booser
Timothy L Madden
Cindy Lipsanen
Linda Yuan
Abenaa M Brewster
Massimo Cristofanilli
Kelly K Hunt
Thomas A Buchholz
James Zwiebel
Vicente Valero
Gabriel N Hortobagyi
Francisco J Esteva
The University of Texas MD Anderson Cancer Center · USNational Cancer Institute · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
Phase I Studies of Targeted Anti-Cancer TherapiesU01CA062461 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI YAO, JAMES C · 1994 to 2013
$7.2M
LIPOSOMAL BCL-2 ANTISENSE THERAPY FOR SOLID TUMORSK23CA082119 · NCI · UNIVERSITY OF TEXAS MD ANDERSON CAN CTR · PI ESTEVA, FRANCISCO J · 1999 to 2003
$544k
NCI NIH HHS K23 CA082119NCI NIH HHS K23 CA82119NCI NIH HHS N01 CM17003NCI NIH HHS P30 CA016672NCI NIH HHS U01 CA062461
6 · The paper itself

Abstract

purposePreclinical data showed enhancement of breast cancer cell death when G3139 was combined with anthracyclines and taxanes. We evaluated the efficacy and safety of a Bcl-2 antisense oligonucleotide, G3139, in combination with doxorubicin (A) and docetaxel (T) in patients with locally advanced breast cancer (LABC). EXPERIMENTAL

designFollowing a brief phase I to determine the phase II dose, patients with locally advanced breast cancer received G3139 administered by continuous i.v. infusion for 5 to 7 days with bolus A (50 mg/m2) and T (75 mg/m2) administered on either day 3 or 6 of therapy with G3139. Cycles were repeated every 21 days x 6 in the neoadjuvant setting. Serial plasma samples were obtained for pharmacokinetic analysis. Tissue samples were obtained before and after therapy for pharmacodynamic analysis of Bcl-2 expression.

resultsThirty patients (median age, 49 years; range, 24-71 years) received 160 cycles. During the phase I portion of the trial, the dose of G3139 was escalated from 3 to 7 mg/kg/d (i.v. for 5 days) in combination with AT. During the phase II portion of the trial, several doses and schedules of G3139 were evaluated. There were no pathologic complete responses. Pharmacodynamic studies showed limited Bcl-2 down-regulation in the primary tumors.

conclusionsG3139 in combination with doxorubicin and docetaxel is well tolerated. No pathologic complete response was seen and pharmacodynamic studies showed very little down-regulation of Bcl-2 in primary tumors, perhaps related to issues with insufficient drug delivery to the intact tumor.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDocetaxelDoxorubicinFemaleHumansMiddle AgedProto-Oncogene Proteins c-bcl-2Reverse Transcriptase Polymerase Chain ReactionTaxoidsThionucleotidesDocetaxelDoxorubicinoblimersenProto-Oncogene Proteins c-bcl-2TaxoidsThionucleotides

Identifiers

PMID19047121
PMCPMC4375958
OpenAlexW2121896572

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.