NCT05076695 (NeoTPPF) is a Phase 2 clinical trial of Palbociclib in Estrogen Receptor-positive Breast Cancer, sponsored by Fudan University.

Who is sponsoring NCT05076695?

NCT05076695 is sponsored by Fudan University.

What drugs are being tested in NCT05076695?

Interventions in NCT05076695: Palbociclib, trastuzumab, pyrotinib, fulvestrant.

What condition does NCT05076695 study?

NCT05076695 studies Estrogen Receptor-positive Breast Cancer, HER2-positive Breast Cancer.

Is NCT05076695 still recruiting?

NCT05076695 is currently status unknown. Last updated 13 October 2021.

Last reviewed 2021-10-13 · How we verify

NCT05076695: NeoTPPF

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

Neoadjuvant With Trastuzumab, Pyrotinib Plus Palbociclib and Fulvestrant in HER2-positive, ER-positive Breast Cancer

Status unknown Phase 2 Last updated 13 October 2021

What this trial tests

Phase 2 trial testing Palbociclib in Estrogen Receptor-positive Breast Cancer in 37 participants. Status unknown.

Timeline

15 October 2021

Primary endpoint
15 October 2023

15 October 2024

Quick facts

Lead sponsor	Fudan University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	15 October 2021
Primary completion	15 October 2023
Estimated completion	15 October 2024
Sites	1 location across China

Drugs / interventions tested

Palbociclib (Palbociclib) — full drug profile →
trastuzumab (trastuzumab) — full drug profile →
pyrotinib — full drug profile →
fulvestrant (fulvestrant) — full drug profile →

Conditions studied

Estrogen Receptor-positive Breast Cancer — all drugs for Estrogen Receptor-positive Breast Cancer →
HER2-positive Breast Cancer — all drugs for HER2-positive Breast Cancer →

Sponsor

Fudan University

Who can join

18 and older, female only, with Estrogen Receptor-positive Breast Cancer or HER2-positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective Single-arm Study to Investigate the Efficacy and Safety of Neoadjuvant treatment with trastuzumab and pyrotinib plus palbociclib and fulvestrant in HER2-positive, ER-positive breast cancer.

Publications & conference data

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

Neratinib for HER2-positive breast cancer with an overlooked option.
Guo L, Shao W, Zhou C, Yang H, et al · · 2023 · cited 33× · PMID 37803271 · DOI 10.1186/s10020-023-00736-0
Novel HER-2 Targeted Therapies in Breast Cancer.
Fernandes CL, Silva DJ, Mesquita A. · · 2023 · cited 9× · PMID 38201515 · DOI 10.3390/cancers16010087
Clinical considerations of CDK4/6 inhibitors in HER2 positive breast cancer.
Zhang C, Zhou F, Zou J, Fang Y, et al · · 2023 · cited 3× · PMID 38293701 · DOI 10.3389/fonc.2023.1322078

Verify or expand the search:

Other trials of Palbociclib

Trials testing the same drug.

NCT07492641 — BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer · Phase 3 · not yet recruiting
NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting
NCT07123090 — A Study of Sasanlimab, Palbociclib and Axitinib in Metastatic Renal Cell Carcinoma · Phase 2 · recruiting
NCT06997029 — A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors · Phase 1 · recruiting

Other recruiting trials for Estrogen Receptor-positive Breast Cancer

Currently open trials in the same condition.

NCT06439693 — The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer · Phase 2 · recruiting
NCT04597580 — Personalised Disease Monitoring in Metastatic Breast Cancer · active not recruiting
NCT02957968 — Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca · Phase 2 · active not recruiting
NCT01953588 — Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery · Phase 3 · active not recruiting

Other Fudan University trials

Trials by the same sponsor.

NCT06196671 — Oncolytic Virus Plus PD-1 Inhibitor to Patients With Advanced Pancreatic Cancer · Phase 2 · not yet recruiting
NCT07423611 — ctDNA-Guided Chemotherapy Omission With Ribociclib Plus Endocrine Therapy in HR-Positive/HER2-Negative Breast Cancer · Phase 2 · not yet recruiting
NCT07410559 — Neoadjuvant Imlunestrant Plus Abemaciclib Treatment Guided by Ki67 Index After 2 Weeks for ER-Positive HER2-Negative Bre · Phase 2 · not yet recruiting
NCT07490119 — Becotatug Vedotin Combined With Cetuximab in the Later-line Treatment of Metastatic RAS Wild-type Colorectal Cancer · Phase 2 · not yet recruiting
NCT07497919 — A Study of Becotatug Vedotin Combined With Pucotenlimab in the Treatment of EGFR-Positive Advanced Penile Cancer · Phase 2 · 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 NCT05076695 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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 Fudan University
Last refreshed: 13 October 2021

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/NCT05076695.

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