Breast cancer surgery – Jana de Boniface's research group

We conduct both register-based and prospective clinical research aiming to individualise and de-escalate breast cancer surgery to minimize its potentially negative impact on patients' quality of life without compromising survival outcomes.

Our Breast cancer surgery research group includes a core of PhD students and postdocs cooperating with affiliated multidisciplinary researchers from the fields of epidemiology, biostatistics, oncology, nursing, exercise oncology, imaging and pathology/translational research. We have a strong focus on patient-centered clinical research with extensive national and international collaboration. Below follow some examples of ongoing research projects:

The SENOMAC Trial

This international randomized non-inferiority trial included patients with clinically node-negative breast cancer and 1-2 sentinel lymph node macrometastases in five European countries between January 2015 and December 2021. The aim was to show the non-inferiority of the omission of completion axillary dissection regarding the primary endpoint overall survival. The study population consists of 2766 randomized patients. The secondary endpoint recurrence-free survival has been published in the New England Journal of Medicine in April 2024 and shows no benefit of completion axillary dissection after a median follow-up of four years. Instead, we could show that patients avoiding completion axillary dissection report significantly less arm problems after surgery. The trial is supported by funding from Vetenskapsrådet, Cancerfonden, Bröstcancerförbundet, and the Nordic Cancer Union. Read more in the website https://senomac.se/

The Neo-ACT Trial

This international randomized trial test the hypothesis that a remote physical exercise intervention via a mobile application improves pathological complete response rates in patients with breast cancer receiving preoperative systemic treatment. Apart from this primary endpoint, the trial explores patient-reported quality of life, toxicity, treatment completion rates, imaging-based tumor response and residual cancer burden, in addition to a number of translational hypotheses using blood, tissue, and faeces samples. The trial has opened at the end of 2022 and has so far recruited over 150 of 790 planned patients. The trial is supported by funding from Vetenskapsrådet, Bröstcancerförbundet, Cancerfonden and Radiumhemmets forskningsfonder. Please go to the separate tab to read more about this project

Stockholm Breast Reconstruction Database

This population-based database includes all women who have received immediate implant-based breast reconstruction in Stockholm in the years 2005-2015. It encompasses a wide range of clinical variables and follow-up and has enabled us to investigate patient-reported outcomes, consequences of postoperative radiotherapy, age inequality and oncological safety of diverse surgical concepts. 

The Stockholm DCIS project

This project aims to investigate surgical and oncological outcomes after oncoplastic breast-conserving surgery for ductal carcinoma in situ. Several clinical collaborators are collecting clinical data from medical charts to complete data received from the National Quality Register for Breast Cancer. Secondary aims are to investigate the role of preoperative MRI in these patients, surgical margins and reoperation rates.

The AXSANA Study

This is a enormous international effort initiated by the EUBREAST group, prospectively including patients with clinically node-positive breast cancer who receive preoperative systemic treatment and thereby convert to clinical node negativity. The main aim is to study different surgical approaches in different countries and evaluate their impact on survival, diagnostic accuracy and patient-reported arm function and quality of life. Our group is responsible for the collection and reporting of patient-reported data.

The OPBC02-PREPEC Trial

This is an international randomised trial evaluating physical well-being as reported by patients after either submuscular placement of the implant in immediate breast reconstruction, or implant placement on top of the pectoral muscle. Our group leader is the national coordinator for Sweden and responsible for reporting early complications. 

Staff and contact

All members of the group

Other people connected to the group

  • Liu, Yihang
  • Obondo, Christine

Visiting address

Karolinska Institutet, Department of Medical Epidemiology and Biostatistics, Nobels väg 12A, Stockholm, 17177, Sverige

Postal address

Karolinska Institutet, Department of Medical Epidemiology and Biostatistics, PO Box 281, Stockholm, 17177, Sverige

The Neo-ACT trial

Person tying shoelaces on running shoes

The Neo-ACT trial is a randomized study to examine if a physical exercise intervention during neoadjuvant chemotherapy for breast cancer (NACT) can increase pathological complete response rates (pCR rates) in breast cancer.

Neoadjuvant chemotherapy (NACT) is increasingly used in breast cancer. The best proof of NACT efficacy is pathological complete response (pCR), i.e. the absence of invasive tumour on post-NACT on surgical histopathology. While it is known that physical exercise can help patients to better tolerate often harsh cancer treatments, it is an emerging area of research to understand if and how exercise exerts anti-tumour effects and improves oncological outcomes.

The main aim of the Neo-ACT trial is to examine if a physical exercise intervention during NACT can increase pCR rates in breast cancer. Secondary aims are to evaluate long-term disease-related outcomes (i.e., overall survival, relapse-free and distant metastasis-free survival), patient-reported outcomes (health-related quality of life, level of functioning), cancer treatment-related toxicities (i.e., cardiovascular toxicity, cognitive dysfunction, chemotherapy completion rates) and to perform translational analyses to further elucidate biological processes on how physical exercise affects tumor metabolism.

790 patients with primary invasive breast cancer will be randomized to either a 6-month individualised intervention of high-intensity interval and resistance training supported by an exercise app, or usual care, aiming at 712 evaluable patients

The Neo-ACT trial is conducted according to Good Clinical Practice requirements and regularly monitored by Clinical Research Organisations (CROs) in each participating country.

Good Clinical Practice (GCP) is the international ethical, scientific, and practical standard to which all clinical research is conducted. It is important that everyone involved in research is trained or appropriately experienced to perform the specific tasks they are being asked to undertake.

Contact 

Sponsor: Karolinska Institutet

Sponsor representativeJana.de-boniface@ki.se

Project management and general questions: Marie.Westman@cytel.com

Specific questions about excercise: Martina.Rossland@ki.se

CRF: yvonne.larsen@regionstockholm.se

Randomization, data management, technical support CRF and ALEA: mats.hellstrom@regionstockholm.se

Technical support Dynareg: chrille@lagerros.se

Study Protocol Neo-ACT

The Neo-ACT trial includes patients according to the following inclusion and exclusion criteria:

Inclusion criteria

  • Patients with primary invasive breast cancer cT1-T3 cN0-2
  • Full tumour biology (ER, PR, HER2, tumour grade, and Ki67) available before initiation of NACT
  • Oral and written consent
  • Age ≥ 18 years

Exclusion criteria

  • Bilateral invasive breast cancer
  • Pregnancy or breast-feeding
  • The presence of musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise and testing demands of the trial
  • Currently performing equal to or more than 150 mins of moderate to high intensity aerobic exercise plus 2 sessions per week of moderate intensity resistance exercise
  • Inability to complete baseline physical exercise test 
  • Inability to access and/or use trial technology (app, activity tracker) 

After signing the informed consent form, patient will be randomised to one of two groups:

Standard care group: Usual care

Intervention group: Physical exercise intervention

Stratification at the moment of computerized randomization will be done based on site of treatment (hospital) and biological tumour subtype (ER+HER2-, ER+HER2+, ER-HER2+, ER-HER2-).

For further details on treatment, follow-up and registration please refer to Study Protocol.

In order to access patient information, please refer to tab "Investigator Site File”.

Safety - Neo-ACT

Serious Adverse Events (SAEs) related to the exercise intervention (Arm B) and to any general exercise performed by the patient without participating in the intervention (Arm A) must be reported within 24 hours after knowledge of the event.

For definition of AEs to be reported/not reported, see protocol.

Kindly please send the SAE-form to Professor Yvonne Wengström, email: yvonne.wengstrom@ki.se

The Neo-ACT trial participating sites

The following sites are registered for participation in the Neo-ACT trial, alongside with start-up dates for the individual sites. Exact dates for the remaining sites will be published when scheduled.

Sweden

1. Karolinska University Hospital

2. Capio St. Göran’s Hospital

3. Southern General Hospital (Södersjukhuset)

4. Sahlgrenska University Hospital

5. Sundsvall Hospital 

6. Skaraborg Hospital, Lidköping and Skövde

7. Västmanlands Hospital, Västerås

8. Norrland University Hospital, Umeå 

Finland

11. HUS Helsingfors Universitetssjukhus

Publication

Physical exercise during neoadjuvant chemotherapy for breast cancer as a mean to increase pathological complete response rates: Trial protocol of the randomized Neo-ACT trial.
de Boniface J, Altena R, Haddad Ringborg C, Bolam KA, Wengström Y
PLoS One 2022 ;17(10):e0274804