Trial · NCT07884721
Fasten Onco Digital Therapy During Neoadjuvant Treatment for Triple-Negative Breast Cancer
NCT07884721, Not applicable, Not yet recruiting, FASTEN
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fasten Onco Digital Therapy During Neoadjuvant Treatment for Triple-Negative Breast Cancer. Trials, record NCT07884721. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07884721
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fasten Onco Digital Therapy During Neoadjuvant Treatment for Triple-Negative Breast Cancer
- NCT number
- NCT07884721
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 144 participants, estimated
- Lead sponsor
- FASTEN
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Interventions
- Fasten Onco, Standard Neoadjuvant Treatment
- First posted
- 2026-10-21
- Last updated
- 2026-10-21
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in FACIT-Fatigue Total Score | Baseline to Day 7 after initiation of Cycle 8 of neoadjuvant treatment | Absolute change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) total score. The FACIT-Fatigue is a 13-item questionnaire assessing fatigue and its impact on daily activities and functioning. The total score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. The primary comparison will assess the difference in change from baseline between the FASTEN Group and the Standard of Care Group. |
| Secondary | Change From Baseline in FACIT-Fatigue Total Score and Subscores Over the Neoadjuvant Treatment Period | Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | Absolute change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) total score and subscores during the neoadjuvant treatment period. The FACIT-Fatigue is a 13-item questionnaire with a total score ranging from 0 to 52, with higher scores indicating less fatigue and better functioning. |
| Secondary | Time to Definitive Fatigue Worsening | From randomization through study completion, up to 3 years | Time from randomization to the first deterioration of ≥6 points out of 52 in the FACIT-Fatigue total score compared with baseline, with no subsequent improvement or deterioration \<6 points until the end of the study, or in a participant who drops out after a ≥6-point decrease resulting in missing data or death. |
| Secondary | FACIT-Fatigue Severity Category | Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | FACIT-Fatigue severity categorized as severe (total score ≤34) or non-severe (total score \>34), including shifts from baseline. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) is a 13-item questionnaire with a total score ranging from 0 to 52, with higher scores indicating less fatigue and better functioning. |
| Secondary | Change From Baseline in FACT-G Total Score at Cycle 8 | Baseline to Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | Absolute change from baseline in the Functional Assessment of Cancer Therapy-General (FACT-G) total score. The FACT-G is a 27-item questionnaire assessing physical, social/family, emotional, and functional well-being. The total score ranges from 0 to 108, with higher scores indicating better quality of life. |
| Secondary | Change From Baseline in FACT-G Total Score Over the Neoadjuvant Treatment Period | Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | Absolute change from baseline in the Functional Assessment of Cancer Therapy-General (FACT-G) total score during the neoadjuvant treatment period. The FACT-G is a 27-item questionnaire assessing physical, social/family, emotional, and functional well-being. The total score ranges from 0 to 108, with higher scores indicating better quality of life. |
| Secondary | Change From Baseline in FACT-G Domain Scores at Cycle 8 | Baseline to Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | Absolute change from baseline in the four Functional Assessment of Cancer Therapy-General (FACT-G) domain scores: Physical Well-Being (0 to 28), Social/Family Well-Being (0 to 28), Emotional Well-Being (0 to 24), and Functional Well-Being (0 to 28). Higher scores indicate better well-being. |
| Secondary | Change From Baseline in FACT-G Domain Scores Over the Neoadjuvant Treatment Period | Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks | Absolute change from baseline in the four Functional Assessment of Cancer Therapy-General (FACT-G) domain scores during the neoadjuvant treatment period: Physical Well-Being (0 to 28), Social/Family Well-Being (0 to 28), Emotional Well-Being (0 to 24), and Functional Well-Being (0 to 28). Higher scores indicate better well-being. |
| Secondary | Time to Definitive FACT-G Deterioration | From randomization through study completion, up to 3 years | Time from randomization to the first deterioration of ≥5 points out of 108 in FACT-G total score compared with baseline, with no subsequent improvement or deterioration \<5 points until the end of the study, or in a participant who drops out after a ≥5-point decrease resulting in missing data or death. |
| Secondary | Time to Definitive FACT-G Subscore Deterioration | From randomization through study completion, up to 3 years | Time from randomization to the first deterioration of ≥3 points in a FACT-G subscore compared with baseline, with no subsequent improvement or deterioration \<3 points until the end of the study, or in a participant who drops out after a ≥3-point decrease resulting in missing data or death. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07884721
GET https://conductscience.org/api/trials/v1/NCT07884721/registered?page=2