NCT00950742 is a Phase 1 clinical trial of Trastuzumab in Breast Neoplasms, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT00950742?

NCT00950742 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT00950742?

Interventions in NCT00950742: Trastuzumab, BIBW 2992.

What condition does NCT00950742 study?

NCT00950742 studies Breast Neoplasms.

Is NCT00950742 still recruiting?

NCT00950742 is currently completed. Last updated 10 February 2025.

Are results published for NCT00950742?

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

Last reviewed 2025-02-10 · How we verify

NCT00950742

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

Phase I Open Label Trial to Assess Safety of BIBW 2992 (Afatinib) in Combination With Herceptin® in Patients With HER2-positive Advanced Breast Cancer.

Completed Phase 1 Results posted Last updated 10 February 2025

What this trial tests

Phase 1 trial testing Trastuzumab in Breast Neoplasms in 18 participants. Completed in 1 October 2013.

Timeline

1 August 2009

Primary endpoint
1 October 2013

1 October 2013

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	1 August 2009
Primary completion	1 October 2013
Estimated completion	1 October 2013
Sites	5 locations across United Kingdom

Drugs / interventions tested

Trastuzumab (trastuzumab) — full drug profile →
BIBW 2992 — full drug profile →

Conditions studied

Breast Neoplasms — all drugs for Breast Neoplasms →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, female only, with Breast Neoplasms. 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.

Number of Participants With Dose Limiting Toxicities (DLT) Primary · 28 days

Number of participants with DLT in the first cycle (28 days) for the determination of the maximum tolerated dose (MTD). Important Limitations and Caveats are provided in the respective section.

Group	Value	95% CI
Afatinib 20mg + Herceptin	4
Afatinib 30mg + Herceptin	2

Maximum Tolerated Dose (MTD) of Afatinib in Combination With Herceptin(R) Primary · 28 days

The MTD was defined as the highest dose at which no more than 1 of 6 patients experienced DLT. It was determined using a standard 3 + 3 dose escalation cohort design. To confirm the MTD, the MTD cohort was to be expanded to 18 patients with no more than 3/18 patients experiencing a DLT. Please refer to CAVEATs and Limitations.

Group	Value	95% CI
Afatinib	20

Number of Patients With Objective Response (OR) Secondary · Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.

Objective tumor response based on response evaluation criteria in solid tumors (RECIST) version 1.1. OR is defined as complete response (CR) or partial response (PR).

Group	Value	95% CI
Afatinib 20mg + Herceptin	2
Afatinib 30mg + Herceptin	0

Number of Patients With Best Overall Response Secondary · Tumor assessment was performed at screening and every 2nd cycle until earliest time of progression, death or end of treatment.

Best overall response based on response evaluation criteria in solid tumors (RECIST) version 1.1. Best overall response is defined as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not evaluable.

Complete Response

Group	Value	95% CI
Afatinib 20mg + Herceptin	0
Afatinib 30mg + Herceptin	0

Partial Response

Group	Value	95% CI
Afatinib 20mg + Herceptin	2
Afatinib 30mg + Herceptin	0

Stable Disease

Group	Value	95% CI
Afatinib 20mg + Herceptin	4
Afatinib 30mg + Herceptin	1

Progressive Disease

Group	Value	95% CI
Afatinib 20mg + Herceptin	0
Afatinib 30mg + Herceptin	1

Not evaluable

Group	Value	95% CI
Afatinib 20mg + Herceptin	10
Afatinib 30mg + Herceptin	0

Progression Free Survival (PFS) Secondary · Baseline until disease progression, death or data cut-off.

PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the response evaluation criteria in solid tumors (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates.

Group	Value	95% CI
Afatinib 20mg + Herceptin	113.0	101.0 – 388.0
Afatinib 30mg + Herceptin	83.5	56.0 – 111.0

Summary of Concentration of Afatinib in Plasma Secondary · 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing

Pre-dose Concentrations of Afatinib in Plasma at Steady State on Days 8, 15 and 29 (Cpre,ss,8, Cpre,ss,15 and Cpre,ss,29) and Maximum Concentration of Afatinib in Plasma at Steady State (Cmax,ss).

Cpre,ss,8 (N=11)

Group	Value	95% CI
Afatinib 20mg + Herceptin	9.75	± 69.5

Cpre,ss,15 (N=13)

Group	Value	95% CI
Afatinib 20mg + Herceptin	9.94	± 72.4

Cpre,ss,29 (N=8)

Group	Value	95% CI
Afatinib 20mg + Herceptin	9.15	± 64.7

Cmax,ss (N=10)

Group	Value	95% CI
Afatinib 20mg + Herceptin	17.9	± 80.9

Time From Dosing to the Maximum Concentration of Afatinib in Plasma at Steady State (Tmax,ss) Secondary · 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing

tmax,ss represents the time from dosing to the maximum concentration of afatinib in plasma at steady state

Group	Value	95% CI
Afatinib 20mg + Herceptin	4.25	0.750 – 7.02

Summary of Concentration of Herceptin in Plasma Secondary · 0.05 hours (h) before dosing and 0.5-1h, 2h, 3h, 4h, 5h, 6h, 8h after dosing

Pre-dose Concentrations of Herceptin in Plasma on Days 8, 15 and 29 (Cpre,8, Cpre,15 and Cpre,29) and Maximum Concentration of Herceptin in Plasma on Days 1, 15 and 29 (Cmax,1, Cmax,15 and Cmax,29).

Cpre,8 (N=14)

Group	Value	95% CI
Afatinib 20mg + Herceptin	43600	± 53.9

Cpre,15 (N=13)

Group	Value	95% CI
Afatinib 20mg + Herceptin	47200	± 47.0

Cpre,29 (N=11)

Group	Value	95% CI
Afatinib 20mg + Herceptin	46200	± 30.9

Cmax,1 (N=14)

Group	Value	95% CI
Afatinib 20mg + Herceptin	122000	± 27.9

Cmax,15 (N=12)

Group	Value	95% CI
Afatinib 20mg + Herceptin	93000	± 24.9

Cmax,29 (N=7)

Group	Value	95% CI
Afatinib 20mg + Herceptin	93200	± 16.9

Adverse events — posted to ClinicalTrials.gov

Time frame: First administration of trial medication until 28 days after last administration of trial medication (up to 1296 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Afatinib 20mg + Herceptin

Serious: 3/16 (19%)

Deaths: —

Afatinib 30mg + Herceptin

Serious: 0/2 (0%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Afatinib 20mg + Herceptin	Afatinib 30mg + Herceptin
Diarrhoea	Gastrointestinal disorders	—	—
Renal failure acute	Renal and urinary disorders	—	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (129 terms — click to expand)

Reaction	System	Afatinib 20mg + Herceptin	Afatinib 30mg + Herceptin
Diarrhoea	Gastrointestinal disorders	—	—
Nausea	Gastrointestinal disorders	—	—
Fatigue	General disorders	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—
Rash	Skin and subcutaneous tissue disorders	—	—
Oral pain	Gastrointestinal disorders	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—
Skin fissures	Skin and subcutaneous tissue disorders	—	—
Dyspepsia	Gastrointestinal disorders	—	—
Mouth ulceration	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Cheilitis	Gastrointestinal disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—
Dysgeusia	Nervous system disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—
Foreign body sensation in eyes	Eye disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Dry mouth	Gastrointestinal disorders	—	—
Stomatitis	Gastrointestinal disorders	—	—
Influenza like illness	General disorders	—	—
Mucosal inflammation	General disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Ejection fraction decreased	Investigations	—	—
Weight decreased	Investigations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—
Ageusia	Nervous system disorders	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	—	—
Dermatitis acneiform	Skin and subcutaneous tissue disorders	—	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Vertigo	Ear and labyrinth disorders	—	—
Conjunctivitis	Eye disorders	—	—
Dry eye	Eye disorders	—	—

Most-reported serious reactions: Diarrhoea, Renal failure acute, Pulmonary embolism.

Data from ClinicalTrials.gov NCT00950742 adverse events section.

Sponsor's own description

Study to determine the Maximum Tolerated dose of BIBW 2992 given in combination with Herceptin®

Publications & conference data

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

Treatment of HER2-positive breast cancer.
Figueroa-Magalhães MC, Jelovac D, Connolly R, Wolff AC. · · 2014 · cited 183× · PMID 24360619 · DOI 10.1016/j.breast.2013.11.011
Potential of afatinib in the treatment of patients with HER2-positive breast cancer.
Geuna E, Montemurro F, Aglietta M, Valabrega G. · · 2012 · cited 15× · PMID 24367201 · DOI 10.2147/bctt.s25868

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 Neoplasms

Currently open trials in the same condition.

NCT07214532 — Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer · NA · recruiting
NCT07500428 — Construction of a Benchmark for Breast Ultrasound AI Interpretation and Performance Evaluation of Multimodal AI Models · recruiting
NCT07581834 — Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multic · Phase 2 · recruiting
NCT07222215 — PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA) · Phase 2 · recruiting
NCT07465393 — Facility-Based Multi-Modal Rehab vs. Home-Based Resistance Exercise for Quality of Life in Breast Cancer Survivors · NA · recruiting

Other Boehringer Ingelheim trials

Trials by the same sponsor.

NCT07044700 — Real-world Comparative Effectiveness and Safety of Jardiance in Chinese Patients With Heart Failure of Reduced Ejection · not yet recruiting
NCT07047508 — Real-world Study to Describe the Effectiveness and Safety Outcomes of Jardiance in Chinese Patients With Heart Failure a · not yet recruiting
NCT07366034 — A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With I · Phase 3 · not yet recruiting
NCT07531628 — A Study to Test How Verducatib is Taken up in the Body of Healthy Chinese Participants · Phase 1 · not yet recruiting
NCT07497087 — A Study to Test Whether Nerandomilast Helps People With Systemic Sclerosis · Phase 3 · not yet 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 NCT00950742 (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 Boehringer Ingelheim
Last refreshed: 10 February 2025

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/NCT00950742.

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