Analyses are ongoing in the Karisma 2 Biopsy study. Karisma 2 Biopsy is a nested cohort within the Karisma 2 clinical trial on low-dose tamoxifen, conducted during 2017-2019 in Sweden. In all, 96 participants donated breast biopsied before and after treatment with tamoxifen or placebo. Analyses are ongoing and results are expected after the summer.
We have now completed the Karisma 2 randomised clinical trial on low-dose tamoxifen. In all, 1,440 women were included in the Swedish two-centre study, at Södersjukhuset in Stockholm and at Unilabs in Lund. The results are being analysed and the first paper is expected to be published after the summer 2020. Karisma-2 is a dose optimisation…
Doctoral student Shadi Azam has recently published two papers investigating mammographic density change using the KARMA cohort.
The last participants have now ended their participation in Karma Crème-1 and the study is officially closed. Analyses are on-going and we are expecting to publish the results during the autumn 2019.
We have now completed the inclusion of 1,440 women in the Karisma-2 double-blinded clinical trial at the breast centre at Södersjukhuset in Stockholm and …
In an exploratory analysis of the KARISMA trial, we took advantage of the full 48-item KARISMA symptom questionnaire to describe the complete side effect spectra at different doses of tamoxifen in healthy women. We found that symptoms and adherence are influenced by menopausal status. Premenopausal women on 20 mg standard dose decreased in weight and…
In the 3-armed double-blinded randomized clinical trial Karma CREME we found that a daily local application on the breast skin with a lotion, containing the tamoxifen metabolite Z-endoxifen, can lower the mammographic breast density already after a few weeks of use. Ninety women, 30 in each dose arm, were randomized to placebo, 10 and 20…
In an analysis of the KARISMA trial investigating tamoxifen response by CYP2D6 metabolizer status we found that discontinuation was higher in poor CYP2D6 metabolizers compared to less efficient metabolizers. One in three ultrarapid CYP2D6 metabolizers discontinued tamoxifen therapy within 1 month, which is substantially higher than in poor metabolizers. In addition we demonstrated that poor CYP2D6 metabolizers…
The results from the 6-armed RCT trial KARISMA 2 show that 2.5 mg of tamoxifen has the potential to be as effective in reducing incidence and recurrence of breast cancer as the established 20 mg dose. Mammographic density change is a proxy for tamoxifen therapy response. We tested if lower doses of tamoxifen were non-inferior…
The thesis included a paper describing a unique tool, STRATUS, for measuring mammographic density regardless of type of image and vendor. This tool and additional mammographic features was used for generating a risk prediction tool and described below, published 20-09-08 (please see below). The thesis also described the Karisma trial where lower doses of tamoxifen…
Shadi Azam has published three papers (see links below) and have one paper in manuscript. Shadi has over the last years worked hard trying to understand the factors behind two mammographic “features” and how these features influence the risk of breast cancer. The features are mammographic density change and breast microcalcifications. None of them are currently particularly…
Karma Kontrast is a randomised clinical trial conducted at the mammography unit at Södersjukhuset (Stockholm South General Hospital), Sweden, in collaboration with researchers at Karolinska institutet. The trial will study if contrast enhanced mammography can be used to improve mammography screening. Karma Kontrast is anticipated to go on until January 2022 and will enrol 420…
Using the prospective screening Karma cohort, an image-based breast cancer 2-year risk model was developed using mammographic features (density, masses, microcalcifications) identified using artificial intelligence. The model could be extended by including a polygenic risk score with 313 single nucleotide polymorphisms. The area under the receiver operating characteristic curve (AUC) for the image-based model was…
The association between annual mammographic density change and breast cancer risk was evaluated using the Karma Cohort (N = 43 810). Density was measured using the STRATUS method and relative mammographic density change was categorized as decreased (>10% decrease per year), stable (no change), or increased (>10% increase per year). Cox proportional hazards regression was…
Around 62,000 Karma participants have recently received emails regarding strategies for breast cancer risk communication. The Karma group aim to collect questionnaire data from the Karma participants on whether they want to know about their individual risk of breast cancer, and if so, how and by whom the risk should be communicated to the women. …
Earlier this month the Swedish national television (SVT) visited the Karma study center and met with professor Per Hall, principal investigator of Karma CREME-1 and other personal at the center. …
The Karma CREME-1 phase 2 clinical trial on topical endoxifen for preventive treatment of women with mammographic breast density is now open for inclusion. The study will include 90 participants and each participant will use topical endoxifen for six months. Preliminary results are expected during spring 2019. …
The Swedish Medical Products Agency (MPA) has approved a Phase 2 study of topical endoxifen for preventive treatment of women with mammographic breast density. …
On the 23rd of February, Dr Johanna Holm defended her thesis entitled “Aggressive breast cancer: epidemiological studies addressing disease heterogeneity”, partly based on Karma samples. …
The Karisma 2 trial on dose optimisation of tamoxifen for preventive use has now reached 800 participants in Lund and in Stockholm and has thereby reached the halfway through milestone. Karisma 2 in expected to close the inclusion by December 2018.