NCT01613482 (TSARINE) is a Phase 3 clinical trial of cerebral prophylactic radiation in Breast Cancer, sponsored by Centre Oscar Lambret.

Who is sponsoring NCT01613482?

NCT01613482 is sponsored by Centre Oscar Lambret.

What drugs are being tested in NCT01613482?

Interventions in NCT01613482: cerebral prophylactic radiation, Trastuzumab, Other chemotherapy in association with Trastuzumab.

What condition does NCT01613482 study?

NCT01613482 studies Breast Cancer, Metastasis, Sur-expressing Her2-neu.

Is NCT01613482 still recruiting?

NCT01613482 is currently terminated. Last updated 12 March 2026.

Last reviewed 2026-03-12 · How we verify

NCT01613482: TSARINE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Interest of the Prophylactic Cerebral Radiotherapy in the Metastatic Breast Cancer Expressing HER2/NEU Treated by Trastuzumab

Terminated Phase 3 Last updated 12 March 2026

What this trial tests

Phase 3 trial testing cerebral prophylactic radiation in Breast Cancer in 13 participants. Terminated before completion.

Timeline

1 January 2008

Primary endpoint
1 August 2009

1 January 2012

Quick facts

Lead sponsor	Centre Oscar Lambret
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	1 January 2008
Primary completion	1 August 2009
Estimated completion	1 January 2012
Sites	26 locations across France

Drugs / interventions tested

cerebral prophylactic radiation
Trastuzumab (trastuzumab) — full drug profile →
Other chemotherapy in association with Trastuzumab — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Metastasis — all drugs for Metastasis →
Sur-expressing Her2-neu — all drugs for Sur-expressing Her2-neu →

Sponsor

Centre Oscar Lambret — full company profile →

Who can join

Adults 18 to 70, female only, with Breast Cancer or Metastasis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

free of cerebral metastasis survival
Time frame: 5 years

Sponsor's own description

Evaluate the survival without metastasis in patients treated by Trastuzumab in association with other chemotherapies for a breast cancer expressing HER2-NEU.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Unsanctifying the sanctuary: challenges and opportunities with brain metastases.
Puhalla S, Elmquist W, Freyer D, Kleinberg L, et al · · 2015 · cited 46× · PMID 25846288 · DOI 10.1093/neuonc/nov023
Preventive strategies against brain metastases: current state of the art and future directions.
Ippen FM, Konen FF, Hau P, Winkler F. · · 2026 · PMID 41928334 · DOI 10.1186/s42466-026-00467-7

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Centre Oscar Lambret trials

Trials by the same sponsor.

NCT07507773 — Assessment of the Long-term Efficacy of Moderately Hypofractionated Neoadjuvant Radiotherapy Soft Tissue Sarcoma in the · Phase 2 · not yet recruiting
NCT06807164 — Serratus Plane Block (SPB) Versus Capsaïcine Versus Botox-A for Chronic Neuropathic Pain in Post-mastectomy Syndrome · Phase 2 · recruiting
NCT06969833 — Prospective Clinico-biological Database of Patients With Ovarian and/or Peritoneal and/or Fallopian Tube Carcinoma · NA · recruiting
NCT06181201 — Association Between the Composition of the Intestinal Microbiota and Tumor Response in Locally Advanced Rectal Cancer · terminated
NCT05286684 — Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01613482 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Centre Oscar Lambret
Last refreshed: 12 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01613482.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing