NCT01187381 (HERODOT) is a clinical trial of Trastuzumab in Breast Cancer, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT01187381?

NCT01187381 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT01187381?

Interventions in NCT01187381: Trastuzumab.

What condition does NCT01187381 study?

NCT01187381 studies Breast Cancer.

Is NCT01187381 still recruiting?

NCT01187381 is currently terminated. Last updated 20 October 2017.

Are results published for NCT01187381?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-10-20 · How we verify

NCT01187381: HERODOT

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

An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Terminated Results posted Last updated 20 October 2017

What this trial tests

trial testing Trastuzumab in Breast Cancer in 250 participants. Terminated before completion.

Timeline

14 April 2010

Primary endpoint
15 October 2015

15 October 2015

Quick facts

Lead sponsor	Hoffmann-La Roche
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	250
Start date	14 April 2010
Primary completion	15 October 2015
Estimated completion	15 October 2015
Sites	1 location across Romania

Drugs / interventions tested

Trastuzumab (trastuzumab) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Treatment Duration With Trastuzumab in the Routine Clinical Practice Primary · Baseline up to 5 years

Group	Value	95% CI
Participants With Breast Cancer	401.90	± 229.867

Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation Secondary · Baseline up to 5 years

Adverse event

Group	Value	95% CI
Participants With Breast Cancer	5

Death

Group	Value	95% CI
Participants With Breast Cancer	2

Progression of the disease

Group	Value	95% CI
Participants With Breast Cancer	18

Administrative reasons

Group	Value	95% CI
Participants With Breast Cancer	30

Doctor's decision

Group	Value	95% CI
Participants With Breast Cancer	40

Other Than the Reasons Reported Above

Group	Value	95% CI
Participants With Breast Cancer	5

Percentage of Participants Who Received Previous Neoadjuvant Therapy Secondary · Baseline up to 5 years

As a neoadjuvant therapy, participants received chemotherapy alone, radiotherapy alone, hormonal therapy alone or combination of these therapies. Percentage of participants who received these therapies is reported.

Chemotherapy and Radiotherapy

Group	Value	95% CI
Participants With Breast Cancer	28

Chemotherapy and Radiotherapy and Hormonal therapy

Group	Value	95% CI
Participants With Breast Cancer	28

Chemotherapy and Hormonal therapy

Group	Value	95% CI
Participants With Breast Cancer	8

Radiotherapy and Hormonal therapy

Group	Value	95% CI
Participants With Breast Cancer	7

Chemotherapy alone

Group	Value	95% CI
Participants With Breast Cancer	21

Radiotherapy alone

Group	Value	95% CI
Participants With Breast Cancer	6

Hormonal therapy alone

Group	Value	95% CI
Participants With Breast Cancer	2

Percentage of Participants Who Had Surgical Procedure for Breast Cancer Secondary · Baseline up to 5 years

Percentage of participants who underwent different types of surgical procedures for breast cancer are reported. Different types of surgical procedures included: breast-conserving surgery; mastectomy; and other (any other surgical procedure except breast-conserving surgery and mastectomy).

Breast-conserving surgery

Group	Value	95% CI
Participants With Breast Cancer	21.2

Mastectomy

Group	Value	95% CI
Participants With Breast Cancer	73.2

Other

Group	Value	95% CI
Participants With Breast Cancer	0.4

Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer Secondary · Baseline up to 5 years

Group	Value	95% CI
Participants With Breast Cancer	82

Progression Free Survival Secondary · Baseline uo tp 5 years

Progression free survival was defined as the time from first dose of trastuzumab to disease progression as assessed by treating physician. Due to observational nature of the study, there was no specific method of assessment used to define progressive disease. Progressive disease was confirmed by treating physician, based on his/her assessment according to local practice.

Group	Value	95% CI
Participants With Breast Cancer	324	84 – 1849

Percentage of Participants by the Site of First Disease Progression Secondary · Baseline up to 5 years

Bone

Group	Value	95% CI
Participants With Breast Cancer	11

Brain

Group	Value	95% CI
Participants With Breast Cancer	32

Breast

Group	Value	95% CI
Participants With Breast Cancer	9

Liver

Group	Value	95% CI
Participants With Breast Cancer	27

Lung

Group	Value	95% CI
Participants With Breast Cancer	21

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to 5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Participants With Breast Cancer

Serious: 12/250 (5%)

Deaths: —

Serious adverse events (13 terms)

Reaction	System	Participants With Breast C…
Ejection fraction decreased	Investigations	—
Cardiac failure chronic	Cardiac disorders	—
Myocarditis	Cardiac disorders	—
Chills	General disorders	—
Death	General disorders	—
Metastases to liver	Hepatobiliary disorders	—
Jaundice	Hepatobiliary disorders	—
Hepatitis viral	Hepatobiliary disorders	—
Craniofacial fracture	Musculoskeletal and connective tissue disorders	—
Transient ischemic attack	Nervous system disorders	—
Breast cancer metastatic	Reproductive system and breast disorders	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—
Hypertension	Vascular disorders	—

Other adverse events (14 terms — click to expand)

Reaction	System	Participants With Breast C…
Ejection fraction decreased	Investigations	—
Leukopenia	Blood and lymphatic system disorders	—
Hepatocellular injury	Hepatobiliary disorders	—
Edema peripheral	General disorders	—
Hypersensitivity	Immune system disorders	—
Craniofacial fracture	Musculoskeletal and connective tissue disorders	—
Bone pain	Musculoskeletal and connective tissue disorders	—
Dizziness	Nervous system disorders	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—
Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	—
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	—
Erythema	Skin and subcutaneous tissue disorders	—
Rash erythematous	Skin and subcutaneous tissue disorders	—
Herpes zoster	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Ejection fraction decreased, Cardiac failure chronic, Myocarditis, Chills, Death, Metastases to liver, Jaundice, Hepatitis viral.

Data from ClinicalTrials.gov NCT01187381 adverse events section.

Sponsor's own description

This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer. Data will be collected from female participants treated with trastuzumab according to the Summary of Product Characteristics and local protocols. Duration of observation for each participant is from therapy initiation until permanent discontinuation for any cause.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Trastuzumab

Trials testing the same drug.

NCT07413939 — RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastati · Phase 2, PHASE3 · not yet recruiting
NCT07441460 — A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer · Phase 3 · recruiting
NCT07402473 — EUREKA Study:Phase 2 Study to Optimize Neoadjuvant Therapy in HER2-positive Early-stage Breast Cancer · Phase 2 · not yet recruiting
NCT07377643 — IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer · Phase 3 · recruiting
NCT07366840 — RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure · Phase 2, PHASE3 · not yet recruiting

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 Hoffmann-La Roche trials

Trials by the same sponsor.

NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O · Phase 2 · not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in · Phase 3 · recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations · not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A · Phase 3 · recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric · Phase 3 · recruiting

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 NCT01187381 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 20 October 2017

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/NCT01187381.

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