An interventional study of Probiotic and Placebo in Breast Cancer, sponsored by GenMont Biotech Incorporation. Active, not recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by GenMont Biotech Incorporation · Not applicable, Interventional, and Supportive care
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Among 380 studies in Breast Neoplasms with a site in Taiwan — 69 open to participants now, 135 under way, 60 of them phase 3. Breast Neoplasms · Taiwan.
Among the 380 studies in Breast Neoplasms with a site in Taiwan, this one is the 218th largest by planned enrollment of the 332 interventional ones that give a count, is one of 23 that started in 2024, is one of 73 with no phase, reaches primary completion later than 75 of the 134 other live ones, and was the 310th registered.
14,829 studies on the registry are indexed under Breast Neoplasms; 3,318 are open to participants now.
Browse Breast Neoplasms studies →69 of the 380 studies in Breast Neoplasms with a site in Taiwan are open now. Recruiting first, the newest first:
Chung Yuan Christian University · Sites in Taiwan
Ages 20+
Daiichi Sankyo · Sites in Taiwan, United States, Belgium and 5 more countries
Ages 18+
CHING-RONG HUANG · Sites in Taiwan
Ages 18–75 · Women only
BeOne Medicines · Sites in Taiwan, United States, Australia and 13 more countries
Ages 18+
Hoffmann-La Roche · Sites in Taiwan, United States, Argentina and 23 more countries
Ages 18+
A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →
Of the 2,398 Breast Neoplasms studies recruiting now, 1,569 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 20 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
380 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 46 · Phase 2 98 · Phase 3 136 · Phase 4 5
First in 1996; this study’s year is marked. 23 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 72 across 10,900 interventional studies indexed under Breast Neoplasms.
Median enrollment 222 across the 332 interventional studies, 205 across the 46 observational. Of the 183 that completed or were terminated, 103 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
237 of 380 have an industry lead sponsor. The 10 most frequent:
GenMont Biotech Incorporation is the lead sponsor of 11 studies on the registry; none are open to participants now.
GenMont Biotech Incorporation has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
37 of the studies in Breast Neoplasms with a site in Taiwan that are under way reach primary completion within a year, 14 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 |
| NCT04639986Phase 3Gilead SciencesAsian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) | 2026-12 |
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
| 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 |
| NCT04421963Phase 3AstraZenecaRoll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib | 2027-04-06 |
Add all 37 to your calendar (.ics) → With an account.
Among the 380 studies in Breast Neoplasms with a site in Taiwan, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Chemotherapy-associated side-effects would affect therapeutic effect, quality of life, and cause permanent harm to breast cancer patients. This study is designed to explore after consumption of probiotics of lactobacillus composite strain powder sachets for 6 months in breast cancer chemotherapy, and whether the improvement of meliorate the side effects, further assists patients completing the chemotherapy.
In 2020, the incidence rate of women's breast cancer in Taiwan was up to 82.1% . The death rate increased to 16%; in 2021, the ranking rose to no.3, and the death rate grew up to 24.6%. In the decades, breast cancer gradually becomes the dominant malignant women's cancer in Taiwan. Besides the lumpectomy, chemotherapy is one of the dominant and important treatments for breast cancer. Beyond the effects of chemotherapy, several side effects rise up. The most common chemotherapy are anthracyclin drugs (doxorubicin and epirubicin) and taxane (docetaxel and paclitaxel ). There are common side effects including neutropenia, hair loss, vomiting, diarrhea, stomatitis, mucositis, peripheral neuropathy, dermatitis, nephrotoxicity, and hepatotoxicity. Currently, most treatments for chemotherapy-induced side effects are symptomatic treatment, but there is no good solution to prevent it.
The criteria were revised on the registry on Nov 12, 2026. See what changed
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects received two probiotic sachets per day
Dietary Supplement: Probiotic
Subjects received two placebo sachets per day
Other: Placebo
Three-strain probiotic supplement includes Lactobacillus reuteri GMNL-89 (alive), Lactobacillus plantarum GMNL-141 (alive) and Lactobacillus paracasei GMNL-133 (alive).
Also known as: Test group
Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.
Also known as: Control group
Change from 12 weeks in the chemotherapy associated side-effects questionnaire at 24 weeks
The questionnaire will finished to record the side effects, including nausea, vomiting, diarrhea, stomatitis, peripheral neuropathy, skin rashes, and hand-food syndrome before and after the treatment.
Time frame: 24 weeks
Change from 12 weeks in self-record of the FACT-G questionnaire (The Functional Assessment of Cancer Therapy - General; Version 4) at 24 weeks
The FACT-G questionnaire will record the quality of life by subjects at 12-weeks and-24 weeks. There are 4 domains of quality of life will be measured, including physical well-being, social/family well-being, emotional well-being, functional well-being. All domains will sum as total score of 108, and each domain will also evaluated.
Time frame: 24 weeks
Variability in BMI (Body Mass Index)
BMI will calculated with weight and height combined in kg/m\^2. Measured every visit (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 12 weeks
Blood samples will collected to examine the variation of hs-CRP from baseline at 12 weeks.
Time frame: 12 weeks
Change from baseline in levels of hs-CRP (high-sensitivity C-Reactive Protein) in mg/dL at 24 weeks
Blood samples will collected to examine the variation of hs-CRP from baseline at 24 weeks.
Time frame: 24 weeks
Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 12 weeks
Blood samples will collected to examine the variation of IL-6 from baseline at 12 weeks.
Time frame: 12 weeks
Change from baseline in levels of IL-6 (Interleukin-6) in pg/mL at 24 weeks
Blood samples will collected to examine the variation of IL-6 from baseline at 24 weeks.
Time frame: 24 weeks
Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 12 weeks
Blood samples will collected to examine the variation of IL-10 from baseline at 12 weeks.
Time frame: 12 weeks
Change from baseline in levels of IL-10 (Interleukin-10) in pg/mL at 24 weeks
Blood samples will collected to examine the variation of IL-10 from baseline at 24 weeks.
Time frame: 24 weeks
Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 12 weeks
Blood samples will collected to examine the variation of TNF-α from baseline at 12 weeks.
Time frame: 12 weeks
Change from baseline in levels of TNF-α (Tumor Necrosis Factor-α) in pg/mL at 24 weeks
Blood samples will collected to examine the variation of TNF-α from baseline at 24 weeks.
Time frame: 24 weeks
Change from baseline in gut microbiome at 12 weeks
Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 12 weeks by NGS (Next Generation Sequencing) analysis.
Time frame: 12 weeks
Change from baseline in gut microbiome at 24 weeks
Fecal sample will collected to extract DNA from the intestinal microbiota to examine the variations of gut microbiome from baseline at 24 weeks by NGS (Next Generation Sequencing) analysis.
Time frame: 24 weeks
Variability in levels of ALT (Alanine Aminotransferase) in IU/L
ALT levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Variability in levels of AST (Aspartate Aminotransferase) in IU/L
AST levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Variability in levels of Creatinine in mg/dL
Creatinine levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Variability in levels of Hb (Hemoglobin) in g/dL
Hb levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Variability in levels of RBC (Red Blood Cell count) in 10^6/μL
RBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Variability in levels of Ht (Hematocrite) in %
Ht levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Variability in levels of WBC(White Blood Cell count) in 10^3/μL
WBC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Variability in levels of MCV (Mean Corpuscular Volume) in fL
MCV levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Variability in levels of MCH (Mean Corpuscular Haemoglobin) in Pg
MCH levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Variability in levels of MCHC (Mean Corpuscular Haemoglobin Concentration) in g/dL
MCHC levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Variability in levels of ANC (Absolute Neutrophil Count) in mm^3
Total neutrophils and WBC collected from routine medical records at each visit to calculate ANC levels. (week 0. 3. 6. 9. 12. 15. 18. 21. 24) ANC is calculated as 10 x WBC count in 1000s x (%Segment neutrophils + % bands neutrophils).
Time frame: 24 weeks
Variability in levels of platelet in 10^3/μL
Platelet levels will obtained from routine medical records every visit. (week 0. 3. 6. 9. 12. 15. 18. 21. 24)
Time frame: 24 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2024 (actual). Primary completion is estimated for Mar 2027, 34 months after the start.
Of 110 industry-sponsored interventional studies with no phase under Breast Neoplasms, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 59. This study's planned 34 months is above that.
Counting every sponsor, half of 2,772 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 12, 2026: primary completion Dec 2026 → Mar 2027 and completion Dec 2026 → Jun 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Probiotic
GenMont Biotech Incorporation