Trial · NCT07528768
HEADWATERS: Gemcitabine vs Paclitaxel in Metastatic Triple-Negative Breast Cancer in Women of African Ancestry.
NCT07528768, Phase 2, Not yet recruiting, The University of The West Indies
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. HEADWATERS: Gemcitabine vs Paclitaxel in Metastatic Triple-Negative Breast Cancer in Women of African Ancestry. Trials, record NCT07528768. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07528768
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HEADWATERS: Gemcitabine vs Paclitaxel in Metastatic Triple-Negative Breast Cancer in Women of African Ancestry.
- NCT number
- NCT07528768
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 750 participants, estimated
- Lead sponsor
- The University of The West Indies
- Conditions
- Triple Negative Breast Cancer, Metastatic Triple-negative Breast Cancer
- Interventions
- Gemcitabine (1000 mg/m^2), Paclitaxel 80 mg/m2 weekly
- First posted
- 2026-04-14
- Last updated
- 2026-09-22
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Up to 5 years | Time from randomization to first documented disease progression per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria or death, whichever occurs first. |
| Secondary | Overall Survival (OS) | Up to 5 years | Time from randomization to death from any cause |
| Secondary | Quality of Life Score on EORTC QLQ-C30 | Up to 5 years | Quality of life assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Covers 5 functional scales (Physical, Role, Cognitive, Emotional and Social), 3 symptom scales (Fatigue, Pain and Nausea/Vomiting) and a global health status scale. All are scored from 0 to 100 with higher scores corresponding to higher functioning or better quality of life on the functional and global health scales, and higher scores indicating greater severity of symptoms on the symptom scales. |
| Secondary | Quality of Life Score on EORTC QLQ-BR23 | Up to 5 years | Quality of life assessed using the EORTC Quality of Life Questionnaire breast cancer-specific module (QLQ-BR23). This includes 4 functional scales (Body Image, Future Perspective, Sexual Functioning and Sexual Enjoyment) 4 symptom scales (Systemic Therapy Side Effects, Upset by Hair Loss, Arm Symptoms and Breast Symptoms). All scales are scored from 0 to 100, with a high score representing higher functioning/better quality of life on the functional scales and worse symptoms on the symptom scales. |
| Secondary | Incidence of Treatment-Emergent Adverse Events graded by CTCAE v5.0 | Up to 5 years | Occurrence of any treatment-emergent adverse events, graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0). |
Source ClinicalTrials.gov
Outcomes0
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07528768
GET https://conductscience.org/api/trials/v1/NCT07528768/registered