Last reviewed · How we verify
NCT04158947: HER2BAT
A Study of HER2+ Breast Cancer Patients With Active Brain Metastases Treated With Afatinib & T-DM1 vs. T-DM1 Alone
Phase 2 trial testing Afatinib in HER2-positive Breast Cancer in 130 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | xuexin he |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 130 |
| Start date | 10 May 2020 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 March 2024 |
| Sites | 4 locations across China |
Drugs / interventions tested
Conditions studied
- HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →
- Brain Metastases — all drugs for Brain Metastases →
Sponsor
xuexin he
Who can join
Adults 18 to 75, female only, with HER2-positive Breast Cancer or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is being done for the following reasons: The study has two parts. The purpose of the first part (Phase I) of the study is to find out the highest dose of Afatinib that can be given safely with T-DM1. The purpose of the second part of the study (Phase II) is to find out whether the dose of Afatinib with T-DM1 determined in Phase I will keep breast cancer from getting worse for a period of time.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04158947
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Afatinib
Trials testing the same drug.
- NCT07040956 — A Clinical Trial Comparing Low-Dose RT + Targeted Therapy+ Immunotherapy vs Targeted Therapy+ Immunotherapy Alone as Neo · Phase 2 · recruiting
- NCT07010120 — A Clinical Trial of Neoadjuvant Targeted Therapy, Immunotherapy, and Lysogenic HSV-Based Virotherapy in Resectable Head · Phase 1, PHASE2 · recruiting
- NCT06804850 — Neoadjuvant Radiotherapy Plus Targeted Therapy and Immunotherapy vs. Targeted Therapy Plus Immunotherapy in Resectable H · Phase 2 · withdrawn
- NCT06741982 — A Clinical Study on Neoadjuvant Treatment of Resectable Head and Neck Squamous Carcinoma With Immune-targeted Therapy an · Phase 1 · recruiting
- NCT06494189 — Low-dose Radiotherapy Plus Tislelizumab in Combination With Afatinib for Neoadjuvant Treatment of Surgically Resectable · Phase 1 · completed
Other recruiting trials for HER2-positive Breast Cancer
Currently open trials in the same condition.
- NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term · Phase 2 · recruiting
- NCT07377643 — IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer · Phase 3 · recruiting
- NCT07510802 — Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC · Phase 1, PHASE2 · recruiting
- NCT07486089 — Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC) · Phase 1, PHASE2 · recruiting
- NCT07102381 — A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Ca · Phase 2 · recruiting
Other xuexin he trials
Trials by the same sponsor.
- NCT04158856 — Adjuvant Dual Anti-HER2 Therapy in Patients With Small, Node-negative, HER2-positive Breast Cancer · Phase 2 · not yet recruiting
- NCT04158843 — Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04158947 (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 xuexin he
- Last refreshed: 12 May 2020
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/NCT04158947.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing