An interventional study of Individualized interventions in Breast Cancer, Premenopausal Breast Cancer and Hormone Receptor Positive Tumor, sponsored by University of Saskatchewan. Completed at 2 sites in Canada. Open to female participants. Per ClinicalTrials.gov, last updated 2024-12-05.
Sponsored by University of Saskatchewan · Not applicable, Interventional, and Treatment
Among 906 studies in Breast Neoplasms with a site in Canada — 141 open to participants now, 257 under way, 81 of them phase 3. Breast Neoplasms · Canada.
Among the 906 studies in Breast Neoplasms with a site in Canada, this one is the 624th largest by enrollment of the 786 interventional ones that give a count, is one of 41 that started in 2018, is one of 203 with no phase, and was the 563rd registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →141 of the 906 studies in Breast Neoplasms with a site in Canada are open now. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in Canada
University Health Network, Toronto · Sites in Canada
Novartis Pharmaceuticals · Sites in Canada, United States, Australia and 1 more country
British Columbia Cancer Agency · Sites in Canada
Novartis Pharmaceuticals · Sites in Canada, United States, France and 6 more countries
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
906 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 129 · Phase 2 246 · Phase 3 255 · Phase 4 25
First in 1988; this study’s year is marked. 41 started in 2018.
This study's enrollment of 41 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 155 across the 786 interventional studies, 199 across the 110 observational. Of the 574 that completed or were terminated, 230 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
374 of 906 have an industry lead sponsor. The 10 most frequent:
University of Saskatchewan is the lead sponsor of 243 studies on the registry; 34 are open to participants now.
University of Saskatchewan has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
64 of the studies in Breast Neoplasms with a site in Canada that are under way reach primary completion within a year, 15 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
| NCT05038735Phase 3Novartis PharmaceuticalsStudy to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. | 2027-01-28 |
| NCT04906395Phase 3Tolmar Inc.Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer | 2027-01-30 |
| NCT05696626Phase 3LeonaBioEvaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation | 2027-04 |
Among the 906 studies in Breast Neoplasms with a site in Canada, from their registry updates:
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Although combination endocrine therapy has been associated with significant reduction in risk of recurrence in younger women with hormone receptor positive breast cancer, it has been associated with more adverse effects and decline in quality of life (QOL). Various behavioral and complementary interventions can be effective in reducing treatment-related side effects. The study aims to evaluate if individually-tailored behavioral and complementary interventions could improve treatment tolerance and adherence in women with early stage breast cancer. This benefit will be assessed primarily by change in QOL and secondarily by adherence to adjuvant endocrine treatment.
Recent evidence suggest that ovarian suppression in combination with exemestane compared with tamoxifen alone has been associated with significant reduction in risk of breast cancer recurrence in premenopausal women with high risk estrogen or progesterone receptor positive breast cancer. However, combination therapy has been associated with more adverse effects, poor treatment adherence, and decline in quality of life (QOL). Various behavioral and complementary interventions such as exercise, yoga, acupuncture, and massage therapy can be effective to reduce treatment-related side effects and thereby to improve QOL. Nevertheless, there is a paucity of evidence about effect of individualized behavioral and complementary interventions in younger women who are treated with combination endocrine therapy. The study aims to evaluate if younger women with early stage breast cancer treated with combination endocrine therapy could benefit from individualized behavioral and complementary intervention (s) during their treatment. This benefit will be assessed primarily by change in QoL and cognitive function from the baseline measurement and secondarily by adherence to adjuvant endocrine treatment. Furthermore, the study will explore correlation between selection of intervention(s) and various socio-demographic and clinical factors. Forty premenopausal women with early stage breast cancer treated with combination endocrine therapy will be recruited over a two year period in Saskatchewan with a median follow up period of about two years. All participants will be provided a list of interventions that alone or in combination could be helpful to improve treatment tolerance to hormonal therapy. A participant will be able to select one or more intervention based on her preferences. The QOL and cognitive function will be assessed every three months using Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B), FACT - Endocrine System (FACT-ES), and FACT-Cognitive Function scales. Treatment adherence will be monitored monthly basis. Individually-tailored behavioral and complementary interventions could promote self-management and empower the women with early stage breast cancer to manage treatment related side effects.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Exercise, Yoga, massage therapy, acupuncture, and others
Behavioral: Individualized interventions
A participant will be able to select one or more (or no intervention) based on her preferences. Individualized exercise program Yoga and mindfulness Massage therapy Acupuncture Others: Women who are not interested in any above intervention but like to explore other interventions will be offered material pertinent to their choice of complimentary techniques.
Functional Assessment of Cancer Therapy - Breast Symptom Index (FACT-B)
For global assessment of quality of life of women with breast cancer
Time frame: Up to three years from the time of enrolment
Functional Assessment of Cancer Therapy - Endocrine System (FACT-ES)
For the assessment of quality of life of women with breast cancer on endocrine therapy
Time frame: Up to three years from the time of enrolment
Functional Assessment of Cancer Therapy - (FACT)-Cognitive
For the assessment of self-reported cognitive function
Time frame: Up to three years from time of enrolment
Treatment discontinuation rate
Rate of combination of endocrine treatment at 3 year.
Time frame: Up to three years from the time of enrolment
Plan to share: No — If requested in future after meeting all the regulatory requirement data will be shared.
No publications or documents are linked to this record.
Ran from Jul 2018 to primary completion in Nov 2024, 76 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 76 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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