Breast CancerPhase 2B-001NCT04571437
Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)
A Phase 2 study testing Capecitabine and Letrozole 2.5mg in people with Breast Cancer and Estrogen Receptor-positive Breast Cancer, run by Cairo University at 1 site in Egypt.
Trial summary
A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Estrogen Receptor-positive Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Capecitabine and Letrozole 2.5mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 30 Apr 2022
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex
- Age 18-70
- ECOG-PS 0-II.
- Histopathological proof of breast cancer
- ER positive (Allred score of ≥3 out of 8), and HER2 negative by IHC (or ISH if HER2 +2).
- Metastatic/recurrent disease as proven by CT scan, bone scan or clinical examination (for skin lesions). Biopsy of the recurrent lesions is encouraged but not mandatory.
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- Either hormone sensitive setting (Denovo metastatic disease or disease progression after more than 1 year of ending adjuvant endocrine therapy) or secondary resistance to tamoxifen therapy (disease relapse after more than 2 years of starting and less than 1 year of ending adjuvant endocrine therapy, or DP of metastatic disease after more than 6 months of first line tamoxifen).
- Adequate organ function.
- Signed informed consent
Who cannot join
- Inadequate organ functions.
- Disease progression while on prior aromatase inhibitor therapy.
- Primary endocrine resistance.
- Double primary cancer (history of other malignancy apart from a non melanoma skin cancer).
- Refusal to sign consent.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Cairo University
Cairo
Mariam A Saleh, M.D, +201003677227, mariamsaleh309@gmail.com
Loay Kassem, M.D, +201003022907, loay.kassem@cairocure.com
About this study
Official title: Letrozole With or Without Metronomic Capecitabine in First Line Treatment of Patients With ER-positive HER2 Negative Advanced Breast Cancer: A Randomized Phase II Study.
A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.
Read the detailed description
This is a randomized clinical trial that assigns patients with female breast cancer in the metastatic entity or advanced -beyond local disease treatment - entity into two arms. Arm A contains Letrozole with metronomic Capecitabine versus arm B that contains Letrozole alone. This is to be applied on ER positive HER2 negative tumours.
- Being tested
- Capecitabine, Letrozole 2.5mg
- Keywords
- Advanced breast cancer, chemo-hormonal, hormone positive, metronomic capecitabine
- Medical subject headings
- 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 metronomic combined with Letrozole
Letrozole 2.5mgDrug
Also called Femara
Letrozole daily alone
| Study group | Role | What they receive |
|---|---|---|
| Chemo endocrine treatment (A) | Active comparator | Letrozole 2.5mg PO daily + Capecitabine 500mg/m2 bid PO continously Receives: Drug: Capecitabine; Drug: Letrozole 2.5mg |
| Endocrine treatment only (B) | Active comparator | Letrozole 2.5mg PO daily Receives: Drug: Letrozole 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 months Progression free survival rate
Percentage of patients alive and progression-free at 6 months
Measured: 6 months from the start of treatment
Secondary outcomes (8)
Overall response rate
Rate of CR+PR as assessed by the investigator using RECIST 1.1 criteria
Measured: 6 months from the start of treatment
Adverse events rates in both groups
Rates of all grade (grade 1-4) and high grade (grade 3+4) adverse events as assessed by NCI-CTAE v4.0
Measured: 6 months from the start of treatment
Quality of life assessment using FACIT-B questionnare
FACIT-B questionnare will be completed by each patient at baseline and 6 months after randomization
Measured: 6 months
Median progression free survival
comparison of estimated median PFS between both groups
Measured: 18 months
Time to treatment failure
Time from start treatment to progression, death or treatment discontinuation from any cause
Measured: 18 months
Clinical benefit rate
Complete response + partial response + stable disease for 6 months
Measured: After 6 months of treatment
Overall survival
Percentage of patients alive at 24 months
Measured: 24 months
Time to chemotherapy adminstration
Time from randomization to the first chemotherapy administration
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Mar 2020
- Primary completion31 Oct 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Model description
- Patients are assigned into two arms of treatment, arm A contains Letrozole and metronomic Capecitabine while arm B contains Letrozole alone.
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Saleh, Cairo University
- Investigators
- Mariam Saleh, M.D, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571437
- Sponsor's protocol ID
- MD-127-2019
- Acronym
- B-001
- Status last verified
- Sep 2020
- First submitted
- 25 Sep 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Azim HA, Saleh MA, Essam Eldin P, Abdelhafeez AAM, Hassan M, Kassem L. Combination of metronomic capecitabine and letrozole in metastatic hormone receptor positive, HER2 negative breast cancer: a randomized phase II trial. J Chemother. 2025 Apr;37(2):159-167. doi: 10.1080/1120009X.2024.2342741. Epub 2024 May 20.
PubMed 38764430
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole With or Without Metronomic Capecitabine in First Line Treatment of Patients With ER-positive HER2 Negative Advanced Breast Cancer: A Randomized Phase II Study.
- ClinicalTrials.gov ID
- NCT04571437
- Acronym / sponsor ID
- B-001 / MD-127-2019
- Keywords
- Advanced breast cancer, chemo-hormonal, hormone positive, metronomic capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 1 Oct 2020 (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.
A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.
Detailed description
This is a randomized clinical trial that assigns patients with female breast cancer in the metastatic entity or advanced -beyond local disease treatment - entity into two arms. Arm A contains Letrozole with metronomic Capecitabine versus arm B that contains Letrozole alone. This is to be applied on ER positive HER2 negative tumours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients are assigned into two arms of treatment, arm A contains Letrozole and metronomic Capecitabine while arm B contains Letrozole alone.
| Arm | Type | Receives |
|---|---|---|
| Chemo endocrine treatment (A) | Active comparator | Drug: Capecitabine, Drug: Letrozole 2.5mgLetrozole 2.5mg PO daily + Capecitabine 500mg/m2 bid PO continously |
| Endocrine treatment only (B) | Active comparator | Drug: Letrozole 2.5mgLetrozole 2.5mg PO daily |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female sex
- Age 18-70
- ECOG-PS 0-II.
- Histopathological proof of breast cancer
- ER positive (Allred score of ≥3 out of 8), and HER2 negative by IHC (or ISH if HER2 +2).
Key exclusion criteria (5 listed)
- Inadequate organ functions.
- Disease progression while on prior aromatase inhibitor therapy.
- Primary endocrine resistance.
- Double primary cancer (history of other malignancy apart from a non melanoma skin cancer).
- Refusal to sign consent.
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 metronomic combined with Letrozole | Drug | Chemo endocrine treatment (A) |
| Letrozole 2.5mgAlso: FemaraLetrozole daily alone | Drug | Chemo endocrine treatment (A), Endocrine treatment only (B) |
Primary outcome
6 months Progression free survival rate
Time frame: 6 months from the start of treatment
Percentage of patients alive and progression-free at 6 months
8 secondary outcomes
Overall response rate
Time frame: 6 months from the start of treatment
Adverse events rates in both groups
Time frame: 6 months from the start of treatment
Quality of life assessment using FACIT-B questionnare
Time frame: 6 months
Median progression free survival
Time frame: 18 months
Time to treatment failure
Time frame: 18 months
Clinical benefit rate
Time frame: After 6 months of treatment
Overall survival
Time frame: 24 months
Time to chemotherapy adminstration
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Derived from this study: PubMed 38764430Azim HA, Saleh MA, Essam Eldin P, Abdelhafeez AAM, Hassan M, Kassem L. Combination of metronomic capecitabine and letrozole in metastatic hormone receptor positive, HER2 negative breast cancer: a randomized phase II trial. J Chemother. 2025 Apr;37(2):159-167. doi: 10.1080/1120009X.2024.2342741. Epub 2024 May 20.
- Individual participant dataSharing planned: No
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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.
Mariam Saleh, M.D principal investigator
Cairo University
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 and Letrozole 2.5mg in people with Breast Cancer and Estrogen Receptor-positive Breast Cancer, run by Cairo 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 9 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 1 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam Saleh, M.D (+201003677227, mariamsaleh309@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 months Progression free survival rate (time frame: 6 months from the start of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04571437, which also lists 1 linked publication.
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 1 Oct 2020.