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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…

DIetary REstriction as an adjunct to neoadjuvant ChemoTherapy
for HER2 negative breast cancer

PrimaryDoes a peri-chemotherapeutic FMD ameliorate grade III or IV toxicity (Phase II part) and increase pathologic complete response (pCR) in patients with HER2 negative early breast cancer treated with neoadjuvant chemotherapy (Phase III part).…

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence

The purpose of this research study is to evaluate how safe and effective Denosumab is, compared with placebo, in delaying the time it takes for cancer to spread to the bones in subjects with early-stage breast cancer at high risk of recurrence.The…

Magnetic Marker Localization for breast cancer surgery: An exploratory study

The purpose of this clinical study is to investigate surgical usability, patient-reported outcomes and effectiveness of the MaMaLoc technique and compare it with WGL.

The value of completion axillary treatment in sentinel node positive breast cancer patients undergoing a mastectomy: a Dutch multicentre cohort study l

The study aim is to decrease the number of breast cancer patients receiving overtreatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life. Therefore, we investigate whether completion axillary…

A phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician*s choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer;patients

Primary objective: To compare progression-free survival (PFS) as assessed by blinded, central review between patients randomized to niraparib versus physician*s choice. Key secondary objective: To compare overall survival between patients randomized…

Optimizing neoadjuvant systemic treatment in HER2 positive breast cancer - the TRAIN-2 study

To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancerSecondary objectives• To describe the safety of the…

A phase III randomized, double blind, placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative AI treated, locally advanced or metastatic breast cancer who progressed on or after mTOR inhibitor based treatment

Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…

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…

Caphosol as a therapeutic option in patients with breast- or colorectal cancer at risk for chemotherapy-induced oral mucositis

To evaluate the effectiveness of a calcium phosphate mouth rinse (Caphosol) on the burden of disease of moderate and severe oral mucositis (WHO scale grade II-IV). In breast cancer patients receiving FE90C x6 (q3w), FE100C x3 (q3w) followed with…

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 study to determine the effect of post-infusion scalp cooling time in the high dose FEC-regimen

The primary aim of current study is to assess the effect of different cooling times on the efficacy of scalp cooling, thereby improving the results of scalp cooling in the high dose 5-Fluorouracil - Epirubicin - Cyclophosphamide (FEC) regimen. A…

An open label, randomized phase III trial comparing 2.5 year duration of letrozole (Femara) treatment with 5 year duration in patients previously treated for endocrine sensitive early breast cancer

PrimaryTo investigate whether 5 years of extended adjuvant treatment with letrozole results in an improved DFS compared to 2.5 years treatment in patients with early breast cancer previously treated with endocrine agents for 5 yearsSecondaryTo…

Breast cancer with low risk of recurrence:partial and accelerated radiation with three dimensional conformal radiotherapy (3DCRT) vs standard radiotherapy after conserving surgery (phase III study)

The study proposes to evaluate whether partial hypofractionated and accelerated irradiation of the sole surgical cavity, in patients suffering from breast cancer with low risk of local recurrence and who undergo conservative surgery, is not inferior…

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 study of an internet-based cognitive behavioral therapy program for sexuality and intimacy problems in women treated for breast cancer.

The proposed study will evaluate the efficacy of an internet-based cognitive behavioral intervention program designed to alleviate sexuality and intimacy problemens of women who have been treated for breast cancer.

A phase III randomized, double blind placebo controlled study of BKM120 with fulvestrant, in postmenopausal women with hormone receptor-positive HER2-negative locally advanced or metastatic breast cancer which progressed on or after aromatase inhibitor treatment (CBKM120F2302)

Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full…

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…