Triple Negative Breast CancerPhase 2NCT07528768
HEADWATERS: Gemcitabine vs Paclitaxel in Metastatic Triple-Negative Breast Cancer in Women of African Ancestry.
A Phase 2 study testing Gemcitabine (1000 mg/m^2) and Paclitaxel 80 mg/m2 weekly in people with Triple Negative Breast Cancer and Metastatic Triple-negative Breast Cancer, run by The University of The West Indies at 3 sites in 3 countries.
Trial summary
The goal of this clinical trial is to learn if Gemcitabine, a chemotherapy drug that is usually used to treat breast cancer after other treatments have failed, is better at treating triple negative breast cancer in women of African ancestry than Paclitaxel, one of the chemotherapy drugs that is usually used first. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple Negative Breast Cancer, Metastatic Triple-negative Breast Cancer
- What is being tested?
- Gemcitabine (1000 mg/m^2) and Paclitaxel 80 mg/m2 weekly
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Jun 2027to 1 Jun 2034
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self-identified Black women of Jamaican, Barbadian or Ghanaian ancestry
- Age ≥18 years
- Histologically confirmed metastatic triple-negative breast cancer (recent biopsy required)
- ECOG (Eastern Cooperative Oncology Group) performance status 0-1
- No prior systemic therapy for metastatic disease
- Adequate organ function (detailed laboratory criteria specified)
- Written informed consent
- Willingness to provide biospecimens for research
Who cannot join
- Prior gemcitabine, anthracycline, or taxane treatment in any setting
- Active brain metastases requiring immediate treatment
- Pregnant or breastfeeding
- Concurrent participation in other interventional trials
- Medical conditions precluding safe chemotherapy administration
- Inability to provide informed consent
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Barbados1 site
The Queen Elizabeth Hospital
Bridgetown, Saint Michael
Simon Anderson, PhD, simon.anderson@cavehill.uwi.edu
Ghana1 site
Korle Bu Teaching Hospital
Accra, Greater Accra Region
Lily Paemka, PhD, 233 30 295 9246, paemka@ug.edu.gh
Jamaica1 site
The University of the West Indies, Mona
Mona, Kingston
Simone Badal, PhD, 876-325-7366, simone.badal@uwi.edu
Alison E Ayoub, MSc, 8765537242, alison.ayoub@uwi.edu
About this study
Official title: Triple-Negative Breast Cancer From the West African Source to the Caribbean Diaspora: A Phase II Randomized Clinical Trial With Correlative Molecular and Population-Stratified Analysis in Women of African Ancestry With Metastatic Triple-Negative Breast Cancer.
The goal of this clinical trial is to learn if Gemcitabine, a chemotherapy drug that is usually used to treat breast cancer after other treatments have failed, is better at treating triple negative breast cancer in women of African ancestry than Paclitaxel, one of the chemotherapy drugs that is usually used first. People will be invited to participate in the trial if they are women of African ancestry, specifically from Jamaica, Barbados and Ghana, are 18 years or older, have had a biopsy that shows that they have triple negative breast cancer (TNBC), and are willing to take part.
The main questions the trial aims to answer are:
Read more
- Does Gemcitabine stop triple negative breast cancer from growing or spreading better than Paclitaxel?
- Are participants more likely to get better when taking Gemcitabine or Paclitaxel?
- What medical problems do participants have when taking Gemcitabine for breast cancer?
- Do Gemcitabine and Paclitaxel affect Black women of African Ancestry differently than women from other regions or ethnic groups?
To answer these questions, half of participants will be treated with Gemcitabine while half is treated with Paclitaxel. Both drugs are given by injection and have already been approved for breast cancer treatment. Participants will:
- Take Gemcitabine for two weeks followed by a two-week break or take Paclitaxel once a week for the same time period.
- Have some of the cancer tissue that was tested from their biopsy taken for more testing.
- Have a physical exam and a blood test done every 3 weeks.
- Have images of their cancer taken using CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) every 6 weeks.
- Answer a brief questionnaire about how they are feeling every 8 weeks.
- Be checked on every month after treatment is finished to make sure the cancer hasn't come back.
Read the detailed description
This is a Phase II, randomized, open-label, multicenter clinical trial evaluating the second-line chemotherapy drug Gemcitabine compared with standard-of-care Paclitaxel as first-line treatment for women of African ancestry with metastatic triple-negative breast cancer (TNBC).
Eligible participants will be randomized in a 1:1 ratio to one of two treatment arms, stratified by study site (5 major hospitals in Jamaica, Barbados and Ghana). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Participants assigned to the investigational arm will receive Gemcitabine administered on days 1 and 8 of a 21-day cycle. Participants assigned to the control arm will receive Paclitaxel administered weekly according to institutional standard practice.
Tumor assessments- via MRI (Magnetic Resonance Imaging) or CT (Computed Tomography) as appropriate- will be conducted at regular intervals to evaluate disease status. Safety assessments (blood test panels) will occur throughout the study, and patient-reported outcomes will be collected using validated quality-of-life instruments.
Participants will be followed for progression, adverse events and survival outcomes for up to 12 months following treatment initiation. Data will be collected and managed using a secure, HIPAA-compliant electronic data capture system in compliance with HIPAA (Health Insurance Portability and Accountability Act). All analyses will be conducted using de-identified data.
- Being tested
- Gemcitabine (1000 mg/m^2), Paclitaxel 80 mg/m2 weekly
- Keywords
- Triple Negative Breast Neoplasms, Gemcitabine, Paclitaxel, Progression-Free Survival, Overall Survival, Quality of Life, Caribbean, Jamaica, Barbados, Ghana, African-Ancestry, Transatlantic
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine (1000 mg/m^2)Drug
Gemcitabine 1000 mg/m² IV on days 1 and 8 of 21-day cycles until disease progression, unacceptable toxicity, or withdrawal
Paclitaxel 80 mg/m2 weeklyDrug
Paclitaxel 80 mg/m² IV weekly or docetaxel 75 mg/m² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Gemcitabine | Experimental | Gemcitabine 1000 mg/m² IV on days 1 and 8 of 21-day cycles until disease progression, unacceptable toxicity, or withdrawal Receives: Drug: Gemcitabine (1000 mg/m^2) |
| Control - Paclitaxel | Active comparator | Paclitaxel 80 mg/m² IV weekly or docetaxel 75 mg/m² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal Receives: Drug: Paclitaxel 80 mg/m2 weekly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Time from randomization to first documented disease progression per RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria or death, whichever occurs first.
Measured: Up to 5 years
Secondary outcomes (4)
Overall Survival (OS)
Time from randomization to death from any cause
Measured: Up to 5 years
Quality of Life Score on EORTC QLQ-C30
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.
Measured: Up to 5 years
Quality of Life Score on EORTC QLQ-BR23
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.
Measured: Up to 5 years
Incidence of Treatment-Emergent Adverse Events graded by CTCAE v5.0
Occurrence of any treatment-emergent adverse events, graded according to the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Jun 2027 (estimated)
- Primary completion1 Jun 2034 (estimated)
- Study completion1 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of The West Indies
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Kingston Public Hospital, University of Ghana, AntiCancer Research Jamaica
- Responsible party
- Principal investigator, Simone Badal, The University of The West Indies
- Investigators
- Magdalene Nwokocha, DM, MBBS, Study director, University Hospital of the West Indies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528768
- Sponsor's protocol ID
- CREC-MN.013,2025/2026
- Status last verified
- Jul 2026
- First submitted
- 30 Dec 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available after the conclusion of the study to researchers with approved proposals via email request. Data sharing will require a signed data use agreement and be determined on a case-by-case basis.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple-Negative Breast Cancer From the West African Source to the Caribbean Diaspora: A Phase II Randomized Clinical Trial With Correlative Molecular and Population-Stratified Analysis in Women of African Ancestry With Metastatic Triple-Negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT07528768
- Acronym / sponsor ID
- CREC-MN.013,2025/2026
- Keywords
- Triple Negative Breast Neoplasms, Gemcitabine, Paclitaxel, Progression-Free Survival, Overall Survival, Quality of Life, Caribbean, Jamaica
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- The University of The West IndiesUniversity, hospital or other
- Collaborators
- Wellcome Trust, Kingston Public Hospital, University of Ghana, AntiCancer Research Jamaica
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 1 Jun 2034 (estimated)
- Study completion
- 1 Jun 2034 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if Gemcitabine, a chemotherapy drug that is usually used to treat breast cancer after other treatments have failed, is better at treating triple negative breast cancer in women of African ancestry than Paclitaxel, one of the chemotherapy drugs that is usually used first. People will be invited to participate in the trial if they are women of African ancestry, specifically from Jamaica, Barbados and Ghana, are 18 years or older, have had a biopsy that shows that they have triple negative breast cancer (TNBC), and are willing to take part.
The main questions the trial aims to answer are:
- Does Gemcitabine stop triple negative breast cancer from growing or spreading better than Paclitaxel?
- Are participants more likely to get better when taking Gemcitabine or Paclitaxel?
- What medical problems do participants have when taking Gemcitabine for breast cancer?
- Do Gemcitabine and Paclitaxel affect Black women of African Ancestry differently than women from other regions or ethnic groups?
To answer these questions, half of participants will be treated with Gemcitabine while half is treated with Paclitaxel. Both drugs are given by injection and have already been approved for breast cancer treatment. Participants will:
- Take Gemcitabine for two weeks followed by a two-week break or take Paclitaxel once a week for the same time period.
- Have some of the cancer tissue that was tested from their biopsy taken for more testing.
- Have a physical exam and a blood test done every 3 weeks.
- Have images of their cancer taken using CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) every 6 weeks.
- Answer a brief questionnaire about how they are feeling every 8 weeks.
- Be checked on every month after treatment is finished to make sure the cancer hasn't come back.
Detailed description
This is a Phase II, randomized, open-label, multicenter clinical trial evaluating the second-line chemotherapy drug Gemcitabine compared with standard-of-care Paclitaxel as first-line treatment for women of African ancestry with metastatic triple-negative breast cancer (TNBC).
Eligible participants will be randomized in a 1:1 ratio to one of two treatment arms, stratified by study site (5 major hospitals in Jamaica, Barbados and Ghana). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or investigator decision.
Participants assigned to the investigational arm will receive Gemcitabine administered on days 1 and 8 of a 21-day cycle. Participants assigned to the control arm will receive Paclitaxel administered weekly according to institutional standard practice.
Tumor assessments- via MRI (Magnetic Resonance Imaging) or CT (Computed Tomography) as appropriate- will be conducted at regular intervals to evaluate disease status. Safety assessments (blood test panels) will occur throughout the study, and patient-reported outcomes will be collected using validated quality-of-life instruments.
Participants will be followed for progression, adverse events and survival outcomes for up to 12 months following treatment initiation. Data will be collected and managed using a secure, HIPAA-compliant electronic data capture system in compliance with HIPAA (Health Insurance Portability and Accountability Act). All analyses will be conducted using de-identified data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Gemcitabine | Experimental | Drug: Gemcitabine (1000 mg/m^2)Gemcitabine 1000 mg/m² IV on days 1 and 8 of 21-day cycles until disease progression, unacceptable toxicity, or withdrawal |
| Control - Paclitaxel | Active comparator | Drug: Paclitaxel 80 mg/m2 weeklyPaclitaxel 80 mg/m² IV weekly or docetaxel 75 mg/m² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Self-identified Black women of Jamaican, Barbadian or Ghanaian ancestry
- Age ≥18 years
- Histologically confirmed metastatic triple-negative breast cancer (recent biopsy required)
- ECOG (Eastern Cooperative Oncology Group) performance status 0-1
- No prior systemic therapy for metastatic disease
Key exclusion criteria (6 listed)
- Prior gemcitabine, anthracycline, or taxane treatment in any setting
- Active brain metastases requiring immediate treatment
- Pregnant or breastfeeding
- Concurrent participation in other interventional trials
- Medical conditions precluding safe chemotherapy administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine (1000 mg/m^2)Gemcitabine 1000 mg/m² IV on days 1 and 8 of 21-day cycles until disease progression, unacceptable toxicity, or withdrawal | Drug | Intervention - Gemcitabine |
| Paclitaxel 80 mg/m2 weeklyPaclitaxel 80 mg/m² IV weekly or docetaxel 75 mg/m² IV every 21 days until disease progression, unacceptable toxicity, or withdrawal | Drug | Control - Paclitaxel |
Primary outcome
Progression-Free Survival (PFS)
Time frame: 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.
4 secondary outcomes
Overall Survival (OS)
Time frame: Up to 5 years
Quality of Life Score on EORTC QLQ-C30
Time frame: Up to 5 years
Quality of Life Score on EORTC QLQ-BR23
Time frame: Up to 5 years
Incidence of Treatment-Emergent Adverse Events graded by CTCAE v5.0
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available after the conclusion of the study to researchers with approved proposals via email request. Data sharing will require a signed data use agreement and be determined on a case-by-case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Magdalene Nwokocha, DM, MBBS study director
University Hospital of the West Indies
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine (1000 mg/m^2) and Paclitaxel 80 mg/m2 weekly in people with Triple Negative Breast Cancer and Metastatic Triple-negative Breast Cancer, run by The University of The West Indies at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Barbados, Ghana, Jamaica. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Simone Badal, PhD (1-876-325-7366, simone.badal@uwi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.