Evidence map›Paper›PMID 33591469›Full record

Trial reportBreast cancer research and treatment2021

Long-term outcome of (neo)adjuvant zoledronic acid therapy in locally advanced breast cancer.

Andrew P Jallouk, Sriram Paravastu, Katherine Weilbaecher, Rebecca L Aft

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00242203 (Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer), which is not on this map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 pooled it
0.8field-weighted citation impact, top 25% 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.

NCT00242203 phase2completednot on this map

Impact of Neoadjuvant Chemotherapy With or Without Zometa on Occult Micrometastases and Bone Density in Women With Locally Advanced Breast Cancer

TypeinterventionalSponsorWashington University School of MedicineRan2002 to 2011Enrolled120ConditionsBreast NeoplasmsArmsZometa, Epirubicin, Docetaxel, Trastuzumab, External beam radiation
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Review
  5. Article
  6. Review
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

4 authors at 2 institutions in 1 country.

Andrew P JalloukDepartment of Medicine, Washington University School of Medicine, St. Louis, MO, USA.ORCID http://orcid.org/0000-0003-4335-7942
Sriram ParavastuUniversity of Missouri-Kansas City School of Medicine, Kansas City, MO, USA.
Katherine WeilbaecherDepartment of Medicine, Washington University School of Medicine, St. Louis, MO, USA.
Rebecca L AftDepartment of Surgery, Washington University School of Medicine, 660 South Euclid Avenue, St. Louis, MO, 63110, USA. aftr@wustl.edu.
Washington University in St. Louis · USUniversity of Missouri–Kansas City · US

Funding

WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Washington University Institute of Clinical and Translational Sciences (TL1)TL1TR002344 · NCATS · WASHINGTON UNIVERSITY · PI Jay F. Piccirillo · 2017 to 2026
$8.5M
NCATS NIH HHS TL1 TR002344NCATS NIH HHS TL1TR002344NCATS NIH HHS UL1 TR002345
6 · The paper itself

Abstract

purposeThe role of zoledronic acid (ZOL), a bone-targeted bisphosphonate, in the treatment of patients with breast cancer remains an active area of study. Here, we report the long-term outcomes of a randomized placebo-controlled phase II clinical trial in which ZOL treatment was added to neoadjuvant chemotherapy in women with locally advanced breast cancer.

methods120 women with clinical stage II-III (≥ T2 and/or ≥ N1) newly diagnosed breast cancer were randomized to receive either 4 mg intravenous ZOL every 3 weeks for 1 year (17 total doses) beginning with the first dose of neoadjuvant chemotherapy, or chemotherapy alone. Clinical endpoints included time to recurrence (TTR), time to bone recurrence (TTBR), time to non-bone recurrence (TTNBR), breast cancer survival (BCS) and overall survival (OS).

resultsWith a median follow-up interval of 14.4 years, there were no significant differences in any of the clinical endpoints studied between the control and ZOL groups in the overall study population. However, ER+/HER2- patients younger than age 45 who were treated with ZOL had significantly worse TTR and TTNBR with a trend towards worse TTBR, BCS and OS (TTR: P = 0.024, HR 6.05 [1.26-29.1]; TTNBR: P = 0.026, HR 6.94 [1.26-38.1]; TTBR: P = 0.054, HR 6.01 [0.97-37.1]; BCS: P = 0.138, HR 4.43 [0.62-31.7]; OS: P = 0.138, HR 4.43 [0.62-31.7]). These differences were not seen in older ER+/HER2- patients or triple-negative patients of any age.

conclusionAddition of ZOL to neoadjuvant therapy did not significantly affect clinical outcomes in the overall study population but was associated with increased extra-skeletal recurrence and a trend towards worse survival in ER+/HER2- patients younger than age 45. These findings suggest caution when using zoledronic acid in young, premenopausal women with locally advanced breast cancer and warrant further investigation. Clinical Trial Registration Number NCT00242203, Date of Registration: 10/17/2005.

Indexed as

Bone Density Conservation AgentsBreast NeoplasmsAgedAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansImidazolesMiddle AgedNeoadjuvant TherapyNeoplasm Recurrence, LocalTreatment OutcomeZoledronic AcidBone Density Conservation AgentsImidazolesZoledronic AcidBisphosphonateBreast cancerNeoadjuvantPremenopausalZoledronic acid

Identifiers

PMID33591469
PMCPMC8068643
OpenAlexW3132799711

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.