Triple -Negative Breast CancerPhase 2NCT07143097
Capecitabine as Maintenance Therapy vs Observation in Early-stage Triple-negative Breast Cancer
A Phase 2 study testing capecitabine in people with Triple -Negative Breast Cancer, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Eligible patients was assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant… 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
- What is being tested?
- capecitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2021to 30 May 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Eligible trial participants will women who has pathologically confirmed invasive breast ductal carcinoma Hormone receptor negative (<1% positive cells by immunohistochemistry staining) and ERBB2 negative.
- Participants had early-stage tumors that were stage T1b-3N0-3cM0, without positive supraclavicular or internal mammary lymph node.
- They received standard treatments, including modified radical mastectomy or breast-conserving surgery, neo-/adjuvant chemotherapy, and radiotherapy according to institutional guidelines.
- patients were able to swallow tablets
- performance status 0 - 1
Who cannot join
- Key exclusion criteria will include Inflammatory or bilateral breast cancer. History of invasive breast cancer or other malignancies; receipt of other biologic agents or immunotherapy.
- Lactation or pregnancy; or severe coexisting illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Capecitabine as Maintenance Therapy Versus Observation on Patients With Early Stage Triple Negative Breast Cancer
Eligible patients was assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy.
Read the detailed description
Eligible patients will randomly open label assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy.
The capecitabine maintenance group will receive oral capecitabine at 650 mg/m2, twice daily continuously for 1 year.
Total follow up of the study is 2 years, one year for drug receving with monthy follow up for adverse effect and the other year for every 3 months follow up to asses DFS and OS.
Collection of capecitabine dose will receive and adverse events will assessed monthly during capecitabine maintenance in the capecitabine group. In both groups, physical examination, assessment of menopausal status, breast ultrasound, and abdominal ultrasound were performed every 3 months during 2 years of follow up; mammography and chest x-ray were performed yearly. Patients who has not experienced recurrence or death at the time of data analysis will censored as alive and event-free at the date of last follow-up.
- Conditions
- Triple -Negative Breast Cancer
- Being tested
- capecitabine
- Keywords
- early stage breast cancer triple negative
- 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.
capecitabineDrug
Also called xeloda
capecitabine 650 mg / m2 twice per day for one year
| Study group | Role | What they receive |
|---|---|---|
| receive low-dose capecitabine maintenance within 4 weeks of finishing the standard adjuvant tr | Experimental | Not described Receives: Drug: capecitabine |
| No Intervention: observation after finishing the standard adjuvant treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse effents of capictabine
Measured: assess the adverse effects of the Capecitabine 6 months after starting treatment.
Secondary outcomes (2)
distant disease-free survival
defined as the time from randomization to the first occurrence of the following events: local relapse, distant metastasis or contralateral breast cancer.
Measured: up to 24 months from diagnosis
overall survival
the time from randomization to death from any cause
Measured: 24 months from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Nov 2021
- Primary completion30 Dec 2024
- Study completion30 May 2025
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.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Hamdy Ali Sayed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143097
- Sponsor's protocol ID
- FMBSUREC/10102021/Sayed
- Status last verified
- Aug 2025
- First submitted
- 9 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Eligible patients will randomly in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy. The capecitabine maintenance group will receive oral capecitabine at 650 mg/m2, twice daily continuously for 1 year.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Capecitabine as Maintenance Therapy Versus Observation on Patients With Early Stage Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT07143097
- Acronym / sponsor ID
- FMBSUREC/10102021/Sayed
- Conditions
- Triple -Negative Breast Cancer
- Keywords
- early stage breast cancer triple negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 27 Aug 2025 (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.
Eligible patients was assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy.
Detailed description
Eligible patients will randomly open label assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy.
The capecitabine maintenance group will receive oral capecitabine at 650 mg/m2, twice daily continuously for 1 year.
Total follow up of the study is 2 years, one year for drug receving with monthy follow up for adverse effect and the other year for every 3 months follow up to asses DFS and OS.
Collection of capecitabine dose will receive and adverse events will assessed monthly during capecitabine maintenance in the capecitabine group. In both groups, physical examination, assessment of menopausal status, breast ultrasound, and abdominal ultrasound were performed every 3 months during 2 years of follow up; mammography and chest x-ray were performed yearly. Patients who has not experienced recurrence or death at the time of data analysis will censored as alive and event-free at the date of last follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| receive low-dose capecitabine maintenance within 4 weeks of finishing the standard adjuvant tr | Experimental | Drug: capecitabine |
| No Intervention: observation after finishing the standard adjuvant treatment | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible trial participants will women who has pathologically confirmed invasive breast ductal carcinoma Hormone receptor negative (<1% positive cells by immunohistochemistry staining) and ERBB2 negative.
- Participants had early-stage tumors that were stage T1b-3N0-3cM0, without positive supraclavicular or internal mammary lymph node.
- They received standard treatments, including modified radical mastectomy or breast-conserving surgery, neo-/adjuvant chemotherapy, and radiotherapy according to institutional guidelines.
- patients were able to swallow tablets
- performance status 0 - 1
Key exclusion criteria (2 listed)
- Key exclusion criteria will include Inflammatory or bilateral breast cancer. History of invasive breast cancer or other malignancies; receipt of other biologic agents or immunotherapy.
- Lactation or pregnancy; or severe coexisting illness.
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 |
|---|---|---|
| capecitabineAlso: xelodacapecitabine 650 mg / m2 twice per day for one year | Drug | receive low-dose capecitabine maintenance within 4 weeks of finishing the standard adjuvant tr |
Primary outcome
adverse effents of capictabine
Time frame: assess the adverse effects of the Capecitabine 6 months after starting treatment.
2 secondary outcomes
distant disease-free survival
Time frame: up to 24 months from diagnosis
overall survival
Time frame: 24 months from diagnosis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Individual participant dataSharing planned: Yes. Eligible patients will randomly in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy. The capecitabine maintenance group will receive oral capecitabine at 650 mg/m2, twice daily continuously for 1 year.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing capecitabine in people with Triple -Negative Breast Cancer, run by Beni-Suef University at 1 site in Egypt.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse effents of capictabine (time frame: assess the adverse effects of the Capecitabine 6 months after starting treatment.). 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 27 Aug 2025.