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HER-2 Positive Breast Cancer clinical trials

View clinical trials related to HER-2 Positive Breast Cancer.

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NCT ID: NCT06100874 Recruiting - Clinical trials for Breast Cancer Female

A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)

Start date: November 20, 2023
Phase: Phase 2
Study type: Interventional

This research study is being done to evaluate the safety and effectiveness of sacituzumab govitecan with trastuzumab (Herceptin, Herceptin Hylecta, or trastuzumab biosimilar) in metastatic HER2+ breast cancer. The names of the study drugs used in this research study are: - Sacituzumab govitecan (a type of antibody-drug conjugate) - Trastuzumab (Herceptin) (a type of monoclonal antibody) - Trastuzumab and Hyaluronidase-oysk (Herceptin Hylecta) (a type of recombinant monoclonal antibody) - Trastuzumab biosimilar drug

NCT ID: NCT05871918 Recruiting - Clinical trials for HER-2 Positive Breast Cancer

A Multicenter, Randomized, Open, Phase III Trial of ddEC-THPvs Evaluating the Efficacy and Safety of TCHP Neoadjuvant Therapy for HER2-positive Breast Cancer

Start date: October 8, 2022
Phase: Phase 3
Study type: Interventional

The study is being conducted to assess the efficacy and safety of anthracycline-containing ddEC-THP intensive regimen and an anthracycline-free TCbHP neoadjuvant therapy for HER2-positive breast cancer

NCT ID: NCT04644406 Not yet recruiting - Clinical trials for HER-2 Positive Breast Cancer

PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study

PETRA
Start date: December 2020
Phase:
Study type: Observational

Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the treatment of HER2-positive breast cancer. EMA's approvals were obtained on phase I pharmacokinetic equivalence trials and phase III clinical trials based on efficacy primary endpoints in the neoadjuvant setting and on Overall Response Rate in metastatic setting. Safety was a secondary endpoints in these trials. Phase III pivotal trials compared trastuzumab biosimilars to Herceptin® in combination with chemotherapy in the neoadjuvant setting and in the metastatic setting. The trials were designed before the approval of pertuzumab (in the neoadjuvant and metastatic settings). Thus, there is no available prospective data on the safety and efficacy of trastuzumab biosimilars in combination with pertuzumab. A biosimilar compound can obtain an extrapolation of its indications to those of the reference biological product since bio-similarity has been demonstrated (ie pharmacokinetic equivalence and clinical studies in the most "sensitive" indications). To date, the use of trastuzumab biosimilar in combination with pertuzumab is allowed, but this combination is not supported by neither scientific evidence nor clinical guidelines. PETRA aims at evaluate the efficacy and safety of the combination of pertuzumab and a trastuzumab biosimilar in real life.

NCT ID: NCT02947685 Active, not recruiting - Clinical trials for HER-2 Positive Breast Cancer

Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer

PATINA
Start date: June 21, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

NCT ID: NCT02675231 Completed - Clinical trials for HER-2 Positive Breast Cancer

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer

monarcHER
Start date: May 23, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 positive (HER2+) locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

NCT ID: NCT02598310 Terminated - Breast Cancer Clinical Trials

Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer

Start date: November 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.

NCT ID: NCT02568839 Active, not recruiting - Clinical trials for HER-2 Positive Breast Cancer

Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer

PREDIX HER2
Start date: November 2014
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B). Switch of therapy to the opposite treatment alternative is applicable in case of lack of response after two courses of treatment, or for medical reasons under exceptional circumstances (drug reaction, other medical conditions) at any point. After termination of the primary treatment follow-up for five years. A translational subprotocol is a mandatory part of the study protocol, with exception for the use of PET-CT evaluations.

NCT ID: NCT02492711 Completed - Clinical trials for HER-2 Positive Breast Cancer

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

SOPHIA
Start date: August 24, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy. A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.

NCT ID: NCT02488564 Completed - Clinical trials for HER-2 Positive Breast Cancer

A Study of Liposomal Doxorubicin + Docetaxel + Trastuzumab + Metformin in Operable and Locally Advanced HER2 Positive Breast Cancer

met-HEReMYTA
Start date: December 17, 2014
Phase: Phase 2
Study type: Interventional

It is a multicenter, open-label, two stage phase II trial, to assess activity, safety and potential early predictors of response in neoadjuvant setting. Patients with operable breast cancer (T1c and cytologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer (T4a-d, N0-N2, M0) with overexpression or amplification of HER2 (AJCC 7th edition 2010) are included in the study. The primary objective is to evaluate the pathological complete response rate (pCR). The secondary objectives are: - to evaluate the clinical response rate (RR). - to evaluate the feasibility and systemic tolerance, with particular attention to cardiac toxicity. - to evaluate the conservative surgery rate. Total duration of the trial is 36 months; planned treatment are 6 cycles of chemotherapy. At every cycle (every 21 days) will be administered: Day 1: Liposome-encapsulated doxorubicin, 50 mg/m2 IV 1 hour infusion; Day 2 and 9: Docetaxel, 30 mg/m2 IV 1 hour infusion; Day 2, 9 and 16: Trastuzumab 4 mg/kg for the first infusion loading dose, then 2 mg/kg/week for subsequent injections. Day -13 to 0: Metformin is administered as single agent. From day -13 to day -11, Metformin 1000 mg will be administered once a day; from day -10 Metformin 1000 mg will be administered twice a day continuously until end of the study treatment.

NCT ID: NCT02326974 Active, not recruiting - Breast Cancer Clinical Trials

T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA

Start date: January 2015
Phase: Phase 2
Study type: Interventional

This research study is studying a combination of drugs as a possible treatment for breast cancer that has tested positive for a protein called HER2. The names of the study interventions involved in this study are: - Trastuzumab emtansine (also called T-DM1) - Pertuzumab