Clinical studies

Sponsor: The Swiss Cancer Institute, University of Basel.

Objective: To demonstrate, in the context of primary surgery, that targeted axillary surgery combined with axillary radiotherapy is superior to complete axillary dissection in terms of quality of life and lymphedema in patients with lymph node-positive breast cancer. An international study comparing targeted axillary surgery combined with axillary radiotherapy in terms of quality of life and incidence of lymphedema. 

Principal Investigator: Prof. François-Clément BIDARD Institut Curie

Objective: To evaluate whether adjuvant treatment with ribociclib (Kisqali) allows for the omission of adjuvant chemotherapy. To demonstrate the non-inferiority of an adjuvant treatment regimen combining ribociclib and ET compared to the same regimen preceded by adjuvant chemotherapy in patients with early-stage breast cancer (EBC) at intermediate risk, HR+, and HER2-, in terms of recurrence-free survival (iBCFS). 

***

CASCADE and DIALOGUE: Cancer Predisposition Cascade Screening for Hereditary Breast/Ovarian Cancer and Lynch Syndromes in Switzerland (2021 – ongoing) - transfered in Basel

Sponsor : University of Basel, Switzerland

Objective : "Cascade" screening is the systematic identification and testing of relatives of a known mutation carrier. Specific objectives of the CASCADE study include investigating patients' genetic testing records and determining their current cancer status and monitoring practices. The study also examines the need for coordination of medical care, psychosocial needs, patient-provider and patient-family communication, quality of life and willingness to advocate for cancer genetic services with relatives. Participation in follow-up can also extend to their relatives.

SAKK 96/12: Prevention of Symptomatic Skeletal Events with Denosumab (Xgeva) Administered every 4 Weeks versus every 12 Weeks – A Non-Inferiority Phase III Trial. (2019 – Ongoing)

Sponsor: The Swiss Group for Clinical Cancer Research (SAKK)

Objective : The clinical objective of this study is to determine whether denosumab 120 mg administered every 12 weeks has a non-inferior efficacy than denosumab 120 mg administered every 4 weeks, is relevant to the quality of life of patients.

SAKK 23/16: Tailored AXIllary Surgery with or without axillary lymph node dissection followed by radiotherapy in patients with clinically node-positive breast cancer (TAXIS). A multicenter randomized phase III trial. (2019 – Ongoing)

Sponsor : The Swiss Group for Clinical Cancer Research (SAKK), transferring sponsorship to the University of Basel in 2021

Objective : The main objective of the study is to show that adapted axillary surgery is not inferior to complete axillary lymph node dissection in breast cancer patients with positive nodes. After surgery and axillary radiation therapy, disease-free survival and long-term side effects are looked at.

IRMA: A multicenter, observational cohort study of women undergoing Immediate breast Reconstruction following MAstectomy (IRMA) (2020 – ongoing)

Sponsor : Breast Center, Thurgau, Switzerland

Objective : The primary objective of this observational study is to track the health indicators of patients undergoing IRMA surgery (mastectomy with immediate reconstruction), which may include complications, tumor recurrence, and aesthetic outcomes. The second objective is to establish evidence-based guidelines for treatment by identifying the optimal strategy for patients undergoing this type of surgery.

"Living after cancer": conceptualization and analysis of the transition of people in remission through the concept of liminality (2023 - ongoing)

Funding: Department of Public Education of the Canton of Geneva and the Geneva Cancer League

Objective : To study how people who have had breast, prostate or colorectal cancer experience the phase after treatment.

Pink Perfect study: Satisfaction study of patients with areola-nipple plaque prosthesis after removal of the areola and nipple (2022-2023)

Sponsor : Pink Perfect

Objective : The main goal of this project is to understand the interest for the patient to use these prostheses and to see their level of satisfaction with the quality of the product.

***

SAKK 95/17: A 24-week activity program in patients with early breast cancer receiving aromatase inhibitor therapy. A multicenter randomized phase III trial. (2019 – 2023)

Sponsor : The Swiss Group for Clinical Cancer Research (SAKK)

Objective : The primary objective of the study is to determine whether a simple outdoor walking intervention, which is easily performed under real-world conditions, starting at the beginning of adjuvant aromatase inhibitor (AI) therapy, can prevent the development of muscle or joint pain/stiffness in breast cancer patients. In addition, this study will evaluate the effect of physical activity on the overall symptom burden and quality of life of patients receiving adjuvant AI therapy.

Sponsor : Breast Cancer Trials (formerly known as Australia and New Zealand Breast Cancer Trials Group) in collaboration with Breast International Group (BIG)

Objective : To determine whether the omission of radiotherapy (RT) is not less than the RT in terms of the interval without local recurrence after breast-conserving surgery in patients with early stage I, luminal A breast cancer who require adjuvant endocrine therapy.

Sponsor : Eli Lilly – Lilly Oncology

Objective  : This Phase 3 study will evaluate the potential of abemaciclib, a potent inhibitor of cyclin-dependent kinases 4 and 6 (CDK4 and 6), to improve adjuvant hormone therapy (ET) compared to standard adjuvant ET alone, in participants with early node hormone early breast cancer with receptor positive (HR+), human epidermal growth factor 2 receptors (HER2+) who are at high risk of recurrence of illness.