Studies
Clinical research on breast cancer
The care of patients participating in trials is an important quality factor of any breast center.
Over the past decades, much has been achieved in the early detection, diagnosis and treatment of breast cancer. Most new insights come from studies in which the best-known therapies are compared with newer, and preferably even better, ones. During clinical trials, patients have the opportunity to be treated with promising new drugs and other forms of therapy. The focus here is always on women who have breast cancer.
Studies conducted at the Breast Center are reviewed by the Ethics Committee of the Canton of Zurich and, where necessary, by Swissmedic. The medical personnel involved in the conduction of the studies are trained in accordance with internationally recognized guidelines.
General
information
Studies help
- avoid unnecessary therapies
- obtain more detailed information about dose and effect
- measure quality of life and side effects of therapy
- assess additional examinations for their value
- disseminate the new findings through a worldwide network of collaborating study groups
- prolong life while preserving the quality of life
Cultural conditions and personal circumstances are always respected. Holistic treatment is provided – even in the event that study participation is discontinued.
The results of such studies are usually not available for several years, so the benefit to patients with breast cancer is not immediately apparent. A patient’s personal study data are always used in encrypted form for data protection.
Our studies
TAXIS-Study (SAKK/University Hospital Basel/OPBC-03): Phase III. Targeted versus radical axillary lymph node surgery followed by radiotherapy in patients with axillary lymph node metastases.
POLAR-Study (IBCSG 59/19): Phase III. Palbociclib in hormone-sensitive, HER2-negative, isolated locoregional breast cancer recurrence.
EXPERT–Study (ANZ 1601/BIG 16-02): Phase III. Adjuvant radiotherapy versus observation in breast-conserving and endocrine therapy of patients with molecularly characterized luminal A breast carcinoma (Prosigna® test).
VISION I–Study (SAKK/CTU Hirslanden/OPBC-06): Vacuum-assisted biopsy immediately before surgery as an intraoperative or preoperative surrogate marker of tumor response to neoadjuvant chemotherapy.
ASCENT 3-Study (Gilead, CRO: ICON): Phase III. A randomized, open-label study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients with Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer whose tumors do not express PD-L1 or in patients previously treated with Anti-PD-(L)1 Agents in the early setting whose tumors do express PD-L1.
ASCENT 4-Study (Gilead, CRO: ICON): Phase III. A randomized, open-label study of Sacituzumab Govitecan and Pembrolizumab versus treatment of physician’s choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced, inoperable, or metastatic Triple-Negative Breast Cancer, whose tumors express PD-L1.
HER2CLIMB-05-Study (Seagon): Phase III. Tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2-positive metastatic breast cancer.
Mallorca-Study (Brust-Zentrum): The relevance of the preoperative marker technique for efficient and safe targeted axillary dissection in patients with breast cancer.
PROMs-Studie: Patient reported outcomes after oncoplastic breast conserving surgery.
MELODY-Study (EUBRAST 4): A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions.
Laser-Study (Novian Health, CRO: Cromsource): Prospective, Multicenter Confirmatory Clinical Evaluation of Novilase® Interstitial Laser Therapy for the Focal Destruction of Malignant Breast Tumors ≤15 mm
CAMBRIA-2: Phase III. Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (oral SERD) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in ER+/HER2-early Breast Cancer (intermediate-high or high risk)
MK2870-010-Studie: MK-2870 (“Antibody Drug Conjugate”) +/- Pembrolizumab versus Therapie der Wahl (Paclitaxel o. Capecitabine o. Liposomal Doxorubicin) bei HR+/HER2- metastasiertem Brustkrebs.
IMPASSION 030-Study (Roche): Atezolizumab (anti-PD-L1-AK) in combination with adjuvant chemotherapy (Taxane/Anthracycline-based) versus adjuvant chemotherapy alone in operable triple-negative breast cancer.
REDUSE-Trial (SAKK 96/12): Denosumab trial, denosumab 1-monthly versus 3-monthly in metastatic breast carcinoma with ≥ 3 bone metastases.
POSITIVE-Study (IBCSG 48/14): Study for patients of childbearing potential after 1.5-2.5 years of endocrine therapy.
SOFT-Trial (IBCSG 24/05) for premenopausal patients: Tamoxifen versus Tamoxifen with GnRH versus Aromasin with GnRH.
PALLAS-Study (ABCSG 42): Endocrine therapy +/- Palbociclib (CDK4/6 inhibitor) for patients with hormone-sensitive breast carcinoma.
APHINITY-Trial: Neoadjuvant/Herceptin and Pertuzumab.
KATHERINE-Study: T-DM1 versus Herceptin in incomplete pathological remission after neoadjuvant chemotherapy.
TARGIT-A-Trial (UCL London): Comparison of intraoperative radiation (IORT) alone with conventional radiotherapy.
TROG-Study: Radiation doses and fractionation schedules for ductal carcinoma in situ (DCIS) of the breast.
ABCSG33R-Study: Axillary registry for sentinel LN metastases without axillary dissection.
TARGIT-B-Trial (UCL London): Intraoperative boost (IORT) versus conventional
PREPEC-Study (OPBC-02/PREPEC): Pre- versus sub-pectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy.
LidERA-Study (Roche GO42784, CRO: PPD): Adjuvant endocrine therapy with giredestrant (oral SERD) vs endocrine therapy of choice for 5 years in hormone sensitive, HER2-negative early breast cancer.
SERENA 4-Study (Astra Zeneca): Camizestrant (oral SERD) + palbociclib + anastrazole placebo vs. anastrazole + palbociclib + SERD placebo in hormone-sensitive, HER2-negative metastatic breast cancer.
SASCIA-Study (Gilead, GBG): Phase III. Postneoadjuvant study evaluating sacituzumab govitecan in primary HER2-negative breast cancer at increased risk of recurrence with incomplete pathologic remission after neoadjuvant chemotherapy.
SOLE-Study (IBCSG 35/07): Study of Letrozole Extension.
SENTINEL-Study (IBCSG 23/09): A randomized trial of axillary dissection versus no axillary dissection for patients with clinically node negative breast cancer. and micrometastases in the sentinel node.
TACHOSIL-Study (SAKK 23/13): Impact of a Surgical Sealing Patch on Lymphatic Drainage after Axillary Lymph Node Dissection for Breast Cancer. A Multicenter Randomized Phase III Trial.
SKINI-Study (Brust-Zentrum): Prospective Evaluation of the Radicality of Breast Tissue Removal with Skin-Sparing and Nipple-Sparing Mastectomy (SSM or NSM).
OncotypeDX-Study (SAKK 26/10): Impact of the Recurrence Score® on recommendations for Adjuvant Treatment in patients with ER-positive breast cancer.
PRIME-Study: Prospective study to measure the impact of MammaPrint on adjuvant treatment in hormone receptor positive HER2 negative breast cancer patients.
ALTTO-Study (IBCSG 36-07): Adjuvant Chemotherapy + Herceptin and/or Lapatinib.
NEOSPHERE- and TRYPHAENA-Studies (Roche): NEOSPHERE- und TRYPHAENA study (Roche): Neoadjuvant Chemotherapy/Herceptin +/- Pertuzumab.
PREFHER-Study (Roche): Adjuvant Herceptin intravenous versus subcutaneous.
Elderly-Study (SAKK 25/14): Eribulin as 1st line treatment in elderly patients (≥ 70 years) with advanced breast cancer: a multicenter phase II trial.
Consilium-Study: Efficiency of the “Consilium” smartphone app for detecting symptoms and treatment side effects in cancer patients depending on form of medication application, age and outpatient characteristics: observational study (OnkoZentrum Zürich).
KAITLIN-Study (Roche): Adjuvant Chemotherapy/T-DM1/Herceptin/Pertuzumab.
eMonarcHER-Trial (Lilly): Endocrine therapy + abemaciclib versus endocrine therapy + placebo in node-positive, hormone-sensitive, early-stage HER2-positive breast cancer (no patient included, early stop of recruiting).
TOUCH-Trial (IBCSG 55-17): Neoadjuvant palbociclib plus letrozole and dual Her2 blockade versus paclitaxel plus dual Her2 blockade for postmenopausal patients with hormone-sensitive, Her2-positive breast carcinoma.
EPIK-B3-Study (Novartis): Alpelisib (BYL719) in combination with Nab-paclitaxel in advanced triple-negative breast cancer with PIK3CA mutation and/or PTEN loss without PIK3CA mutation (no patient included).
WISE-Study (IBCSG 95-17): 24 weeks activity program in patients with early breast cancer receiving aromatase inhibitor therapy.
ELEANOR-Study (Pierre Fabre, CRO: iOMEDICO): Phase IV Observational Study. Neratinib for 1 year in hormone-sensitive, HER2-positive breast cancer, within 1 year of completion of anti-HER2 therapy.
Metformin-Study (IBCSG 40-11): Metformin versus Placebo in hormone-sensitive, HER2-negative breast cancer for 5 years in combination with endocrine therapy.
Interested?
The physicians at the Zurich Breast Center will be happy to provide information on which studies are suitable for which patients. Contact us by phone +41 44 533 81 00 or e-mail info@brust-zentrum.ch with any questions.
