NCT04582968

Pyrotinib Combined With Brain Radiotherapy in Breast Cancer Patients With Brain Metastases

Status unknown Phase 1, PHASE2 Last updated 18 January 2023

What this trial tests

Phase 1, PHASE2 trial testing Pyrotinib Plus Capecitabine combined with brain radiotherapy in Breast Cancer in 39 participants. Status unknown.

Timeline

2 January 2020

Primary endpoint
12 August 2022

12 August 2023

Quick facts

Lead sponsor	Fudan University
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	2 January 2020
Primary completion	12 August 2022
Estimated completion	12 August 2023
Sites	1 location across China

Drugs / interventions tested

• Pyrotinib Plus Capecitabine combined with brain radiotherapy

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Brain Metastases — all drugs for Brain Metastases →
• HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →

Sponsor

Fudan University

Who can join

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

Sponsor's own description

Brain metastases occur in 30-50% of patients with metastatic HER2-positive breast cancer. Pyrotinib is an irreversible pan-ErbB receptor tyrosine kinase inhibitor (TKI) with activity against epidermal growth factor receptor (EGFR)/HER1, HER2, and HER4. This study consists of two parts. In a phase Ib part, investigators will explore the safety and tolerance of Pyrotinib Plus Capecitabine combined with brain radiotherapy. After completing the phase Ib part, investigators will review the data and decide whether this patient is included in before the start of a phase II part. In the phase II part, investigators will evaluate the efficacy of Pyrotinib Plus Capecitabine combined with brain radiotherapy in patients with HER2 positive breast cancer patients with brain metastases.

Publications & conference data

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

1. Brain Metastases in HER2-Positive Breast Cancer: Current and Novel Treatment Strategies.
   Garcia-Alvarez A, Papakonstantinou A, Oliveira M. · · 2021 · cited 77× · PMID 34208287 · DOI 10.3390/cancers13122927
2. Breast Cancer Brain Metastasis: A Comprehensive Review.
   Raghavendra AS, Ibrahim NK. · · 2024 · cited 45× · PMID 38748968 · DOI 10.1200/op.23.00794
3. Beyond HER2: Targeting the ErbB receptor family in breast cancer.
   Drago JZ, Ferraro E, Abuhadra N, Modi S. · · 2022 · cited 39× · PMID 35870237 · DOI 10.1016/j.ctrv.2022.102436
4. Brain Radiotherapy With Pyrotinib and Capecitabine in Patients With ERBB2-Positive Advanced Breast Cancer and Brain Metastases: A Nonrandomized Phase 2 Trial.
   Yang Z, Meng J, Mei X, Mo M, et al · · 2024 · cited 22× · PMID 38175627 · DOI 10.1001/jamaoncol.2023.5791
5. Systemic treatments for breast cancer brain metastasis.
   Chen Q, Xiong J, Ma Y, Wei J, et al · · 2022 · cited 14× · PMID 36686840 · DOI 10.3389/fonc.2022.1086821
6. Radiotherapy for HER 2 Positive Brain Metastases: Urgent Need for a Paradigm Shift.
   Ippolito E, Silipigni S, Matteucci P, Greco C, et al · · 2022 · cited 13× · PMID 35326665 · DOI 10.3390/cancers14061514
7. Combination of Modern Radiotherapy and New Targeted Treatments for Breast Cancer Management.
   Beddok A, Cottu P, Fourquet A, Kirova Y. · · 2021 · cited 13× · PMID 34944978 · DOI 10.3390/cancers13246358
8. Treating Advanced Unresectable or Metastatic HER2-Positive Breast Cancer: A Spotlight on Tucatinib.
   Ulrich L, Okines AFC. · · 2021 · cited 13× · PMID 34079368 · DOI 10.2147/bctt.s268451