Search for a trial

Pertuzumab + trastuzumab (PH) versus PH plus metronomic chemotherapy
(PHM) in the elderly HER2+ metastatic breast cancer population who may
continue on T-DM1 alone following disease progression while on PH / PHM:
an open-label multicentre randomized phase II selection trial of the EORTC
Elderly Task Force and Breast Cancer Group

The main objectives are to evaluate the efficacy (as measured byprogression free survival at 6 months) of pertuzumab combined withtrastuzumab (PH) or PH plus metronomic chemotherapy (PHM) in anelderly metastatic breast cancer population, and to…

A randomized phase II trial of pertuzumab in combination with trastuzumab with or without chemotherapy, both followed by T-DM1 in case of progression, in patients with HER2-positive metastatic breast cancer

Primary objectivesThe primary objective of this trial is to evaluate the efficacy in terms of overall survival (OS) at 24 months of a chemotherapy-free dual HER2-inbibition with trastuzumab and pertuzumab (first-line) followed by T-DM1 (second-line…

A Phase Ib/II Randomized Study of BI 836845 in Combination with Exemestane and Everolimus Versus Exemestane and Everolimus Alone in Women with Locally Advanced or Metastatic Breast Cancer

Objecive of phase I was the determination of the maximum tolerated dose (MTD) and recommended phase II dose of BI836845 in combination with exemestane and everolimus in women with HR+ / HER2- locally advanced or metastatic breast cancer.Ojective of…

A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with
Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus
Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

The primary objective of the study is to assess the progression-free survival (PFS) of oralveliparib in combination with temozolomide (TMZ) or in combination with carboplatin and paclitaxel compared to placebo plus carboplatin and paclitaxel.The…

Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy

The primary objective is to assess safety and efficacy of abiraterone acetate plus prednisone and abiraterone acetate plus prednisone plus exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer…

A multicenter, randomized, double blind, placebo controlled, phase II trial evaluating the safety and efficacy of TKI258 combined with fulvestrant, in postmenopausal patients with HER2- and HR+ breast cancer that have evidence of disease progression on or after prior endocrine therapy

Primary: treatment effect of TKI258 in combination with fulvestrant vs. fulvestrant plus placebo on Progression-Free Survival (voor for each of the 2 groups, namely FGF pathway amplified and regardless of FGF pathway amplification status).Secondary…

A randomized, prospective trial of 3 weeks pre-operative hormonal treatment for hormone receptor positive breast cancer: Anastrozole, Fulvestrant or Tamoxifen Exposure - Response in molecular profile (AFTER).

To investigate prospectively how the "TAMRO-profile" performs in a pre-operative treatment setting. In addition we can examine whether the profile is specific for tamoxifen or is predictive for endocrine resistance in general. Also the…

A randomized pre-surgical pharmacodynamics study to assess the biological activity of LEE011 plus letrozole versus single agent letrozole in primary breast cancer (CLEE011A 2201)

Primary objective: To estimate the difference in anti-proliferative activity of LEE011 600 mg QD and LEE011 400 mg QD in combination with letrozole 2.5 mg QD vs single agent letrozole 2.5 mg QD as measured by changes in Ki-67 levels from baseline to…

High-dose alkylating chemotherapy in oligo-metastatic breast cancer harboring homologous recombination deficiency

This study will investigate whether oligometastatic triple negative or BRCA1/2 related breast cancer can be treated effectively with a multimodality approach including induction chemotherapy, and whether high dose alkylating chemotherapy can improve…

A Randomized Phase II Study Of Reirradiation And Hyperthermia Versus Reirradiation And Hyperthermia Plus Chemotherapy For Locally Recurrent Breast Cancer In Previously Irradiated Area

Primary objective phase II:To explore if there is an indication of a positive effect on local control rate of adding Cisplatin to local reirradiation and hyperthermia to patients with local regional recurrent breast cancer in previously irradiated…

A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study of ABT-869 in Combination With Paclitaxel Versus Paclitaxel Alone as First-line Treatment in Subjects With Locally Recurrent or Metastatic Breast Cancer

To determine the clinical efficacy and toxicity of ABT-869 in combination with paclitaxel in the first-line treatment of subjects with metastatic breast cancer.

RANDOMIZED PHASE II/III STUDY OF INTENSIFIED ALKYLATING AGENT CHEMOTHERAPY WITH PERIPHERAL BLOOD PROGENITOR CELL SUPPORT IN THE PREOPERATIVE CHEMOTHERAPY OF BREAST TUMORS THAT ARE DEFICIENT FOR HOMOLOGOUS RECOMBINATION.

Nearly all patients who die from breast cancer die from the consequences of distant metastases. Adjuvant chemotherapy, either administered before or after surgery, has been shown to reduce the risk of metastases and death. Four main groups of…

Biomarker discovery randomized phase IIb trial with carboplatin-cyclophosphamide versus paclitaxel with or without Bevacizumab as first-line treatment in advanced triple negative Breast cancer (TRIPLE-B study);Title after protocol amendment August 12, 2017:
Biomarker discovery randomized phase IIb trial with carboplatin-cyclophosphamide versus paclitaxel with or without atezolizumaB as first-line treatment in advanced triple negative Breast cancer (TRIPLE-B study)

This study has been transitioned to CTIS with ID 2024-516202-39-00 check the CTIS register for the current data. Modified objectives after implementation of protocol amendment Sept 2024: Primary: 1. Validate the BRCA1-like test* in predicting…

Tailoring neoadjuvant therapy in hormone receptor positive, HER2 negative, luminal breast cancer.

Primary objective:• Determine if ribociclib plus letrozole gives a >=100% improvement in complete cell cycle arrest (CCCA; defined as Ki67 IHC <1%) as compared to chemotherapy in the surgical specimen*.Secondary objective• Study the…

AIPAC (Active Immunotherapy PAClitaxel): A multicentre, Phase IIb, randomised, double blind, placebo-controlled study in hormone receptor-positive metastatic breast carcinoma patients receiving IMP321 (LAG-3Ig fusion protein) or placebo as adjunctive to a standard chemotherapy treatment regimen of paclitaxel.

Primary objectives:* Safety run-in stage: determine the recommended phase two dose for therandomised phase* Randomised stage: to determine efficacy of IMP321 combined with weekly paclitaxel compared to weekly paclitaxel plus placebo in hormone…

A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED WITH PEMBROLIZUMAB COMBINED WITH NAB-PACLITAXEL IN PARTICIPANTS WITH PREVIOUSLY UNTREATED, PD-L1*POSITIVE, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER

Primary Objective: This study will evaluate the efficacy, safety, and pharmacokinetics of RO7247669 plus nab-paclitaxel compared with pembrolizumab plus nab-paclitaxel in patients with previously untreated, locally advanced, unresectable or…

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the
Safety and Efficacy of Agents Targeting DNA Damage Repair in
Combination with Olaparib versus Olaparib Monotherapy in the Treatment
of Metastatic Triple Negative Breast Cancer Patients Stratified by
Alterations in Homologous Recombinant Repair (HRR)-related Genes
(including BRCA1/2)

Olaparib + AZD1775 - this treatment arm was closed.Study objectives are defined for the following patient populations:* *Breast cancer susceptible gene mutation (BRCAm)* = patients from stratum A· *Homologous Recombination Repair gene mutation (HRRm…

Explorative trial to identify the impact of denosumab on the systemic immunity and local immunologic microenvironment in postmenopausal patients with HER2 negative breast cancer.

Primary objective• Determine the change in intratumoral T-cell (CD4, CD8 and Treg) and Myeloid cell (M1/M2 Macrophage, MDSC, DC) numbers and function between the baseline biopsy and the surgical specimen.Secondary objectives• PBMC before start…

A phase II randomized, double-blind placebo controlled, study of letrozole with or without BYL719 or
buparlisib, for the neoadjuvant treatment of postmenopausal women with hormone receptor-positive
HER2-negative breast cancer (CBYL719A2201)

Primary objective: Determine whether treatment with a PI3K inhibitor (BYL719 or buparlisib) plus letrozole leads to an increase in pathologic response compared to treatment with placebo plus letrozole in patients with hormone receptor-positive HER2-…

Open-label Phase 2 study evaluating efficacy and safety of SAR566658 treatment in patients with CA6 positive metastatic Triple Negative Breast Cancer

The goal of the trial is to investigate the safety and efficacy of SAR566658, if it is provided to CA6 protein positive metastaticTBN breastcancer patients.