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neoMONARCH: A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib (LY2835219) in Combination with Anastrozole to those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy with Abemaciclib in Combination with Anastrozole in Postmenopausal Women with Hormone Receptor Positive, HER2 Negative Breast Cancer

The primary objective of Study I3Y-MC-JPBY (JPBY) is to compare the biological activity ofabemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy byassessing the percentage change from the baseline value in…

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…

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 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…

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…

RANDOMIZED PHASE II/III STUDY OF SECOND-LINE ENDOCRINE TREATMENT FOLLOWED BY CAPECITABINE VERSUS CAPECITABINE FOLLOWED BY ENDOCRINE TREATMENT IN PATIENTS WITH METASTATIC ER POSITIVE BREAST CANCER

This trial studies the effects on quality of life and on time to second progression of the sequence endocrine therapy-capecitabine versus the sequence capecitabine-endocrine treatment. It is anticipated that the time on study (which is the time…

An open-label, phase II, single-arm study of everolimus in combination with letrozole in the treatment of postmenopausal women with estrogen receptor positive metastatic breast cancer (CRAD001Y24135)

Primary: to estimate progression-free survival in patients treated with everolimus + letrozole in the first line setting.Secondary: overall response rate, clinical benefit rate, overall survival in the first line setting, progression free survival…

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…

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…

Pilot study on the use of a radiopaque hydrogel during breast conserving surgery with full-thickness closure for target definition and positioning of boost or partial breast irradiation.

Primary objective: Estimate the Conformity Index (Cx) of target definition. Secondary objectives: Estimate the distance between the center of mass (dCOM) of the observers* target volumes, Cavity Visualisation Score (CVS), feasibility of the hydrogel…

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…