Breast CancerPhase 2/3NCT03507465
Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer
A Phase 2/3 study testing Letrozole Plus Low-Dose Metronomic Capecitabine and EC-T in people with Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
Patients with ER+/HER2- breast cancer (presumably the luminal A subtype) could potentially avoid the standard chemotherapy use. Letrozole Plus Low-Dose Metronomic Capecitabine may offer similar efficacy and less toxicity to standard chemotherapy in ER+/HER2- breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Letrozole Plus Low-Dose Metronomic Capecitabine and EC-T
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2017to 29 Nov 2020
- Phase
- Phase 2/3
- 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
- -women (age 18-70 years) with clinical T2-3 N0-1 M0 ER-positive (ER) allred score 4-8，and progesterone receptor-positive (PgR) ，HER2-negative adequate bone marrow reserve (WBC count, 3.5 109/L; platelets, 100109/L; hemoglobin, 10g/dL), hepatic function (AST/ALT bilirubin and alkaline phosphatase levels 1.25 the upper limit of normal value), and renal function (serum creatinine 1.25 the upper limit of normal value).
- Luminal A/ lymph node positive breast cancer or Luminal B breast cancer patients
Who cannot join
- (a) male patients; (b) patients with inflammatory breast cancer or distant metastasis; (c) patients who were previously treated with chemotherapy, radiation therapy or prior treatment with AIs or antiestrogens for breast cancer; (d) patients with a second concomitant neoplasm; and (e) patients who could not meet the eligibility criteria.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong General Hospital
Guangzhou, Guangdong, 510080
Liming Yao, 00862083827812 ext. 20984, 13149395530@163.com
About this study
Patients with ER+/HER2- breast cancer (presumably the luminal A subtype) could potentially avoid the standard chemotherapy use. Letrozole Plus Low-Dose Metronomic Capecitabine may offer similar efficacy and less toxicity to standard chemotherapy in ER+/HER2- breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Letrozole Plus Low-Dose Metronomic Capecitabine, EC-T
- Keywords
- letrozole, metronomic, capecitabine, neoadjuvant, chemotherapy, ER+/HER2-
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Letrozole Plus Low-Dose Metronomic CapecitabineDrug
Letrozole Plus Low-Dose Metronomic Capecitabine
EC-TDrug
Epirubicin/Cyclophosphamide Followed by Docetaxel
| Study group | Role | What they receive |
|---|---|---|
| Letrozole Plus Low-Dose Metronomic Capecitabine | Experimental | Not described Receives: Drug: Letrozole Plus Low-Dose Metronomic Capecitabine |
| EC-T | Active comparator | Not described Receives: Drug: EC-T |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
objective response rate (ORR) measured by breast ultrasound monthly
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start29 Nov 2017
- Primary completion29 Nov 2019 (estimated)
- Study completion29 Nov 2020 (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 Guangdong Provincial People's HospitalThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507465
- Sponsor's protocol ID
- Guangdong General Hospital
- Status last verified
- Mar 2018
- First submitted
- 15 Apr 2018
- Last updated
- 25 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li WP, Zhu T, Hu MX, Yang M, Ji F, Gao HF, Yang CQ, Zhang LL, Cheng MY, Xu FP, Wang K. Comparison of the efficacy and safety of the EC-T (epirubicin/cyclophosphamide followed by docetaxel) and TCb (docetaxel/carboplatin) neoadjuvant regimens in early TOP2A-normal stage II-III breast cancer. Neoplasma. 2020 Nov;67(6):1409-1415. doi: 10.4149/neo_2020_200130N96. Epub 2020 Jul 13.
PubMed 32657611
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT03507465
- Acronym / sponsor ID
- Guangdong General Hospital
- Conditions
- Breast Cancer
- Keywords
- letrozole, metronomic, capecitabine, neoadjuvant, chemotherapy, ER+/HER2-
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 29 Nov 2019 (estimated)
- Study completion
- 29 Nov 2020 (estimated)
- First posted
- 25 Apr 2018 (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.
Patients with ER+/HER2- breast cancer (presumably the luminal A subtype) could potentially avoid the standard chemotherapy use. Letrozole Plus Low-Dose Metronomic Capecitabine may offer similar efficacy and less toxicity to standard chemotherapy in ER+/HER2- breast cancer patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Letrozole Plus Low-Dose Metronomic Capecitabine | Experimental | Drug: Letrozole Plus Low-Dose Metronomic Capecitabine |
| EC-T | Active comparator | Drug: EC-T |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- -women (age 18-70 years) with clinical T2-3 N0-1 M0 ER-positive (ER) allred score 4-8，and progesterone receptor-positive (PgR) ，HER2-negative adequate bone marrow reserve (WBC count, 3.5 109/L; platelets, 100109/L; hemoglobin, 10g/dL), hepatic function (AST/ALT bilirubin and alkaline phosphatase levels 1.25 the upper limit of normal value), and renal function (serum creatinine 1.25 the upper limit of normal value).
- Luminal A/ lymph node positive breast cancer or Luminal B breast cancer patients
Key exclusion criteria (1 listed)
- (a) male patients; (b) patients with inflammatory breast cancer or distant metastasis; (c) patients who were previously treated with chemotherapy, radiation therapy or prior treatment with AIs or antiestrogens for breast cancer; (d) patients with a second concomitant neoplasm; and (e) patients who could not meet the eligibility criteria.
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 |
|---|---|---|
| Letrozole Plus Low-Dose Metronomic CapecitabineLetrozole Plus Low-Dose Metronomic Capecitabine | Drug | Letrozole Plus Low-Dose Metronomic Capecitabine |
| EC-TEpirubicin/Cyclophosphamide Followed by Docetaxel | Drug | EC-T |
Primary outcome
objective response rate
Time frame: 6 month
objective response rate (ORR) measured by breast ultrasound monthly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2018.
- Derived from this study: PubMed 32657611Li WP, Zhu T, Hu MX, Yang M, Ji F, Gao HF, Yang CQ, Zhang LL, Cheng MY, Xu FP, Wang K. Comparison of the efficacy and safety of the EC-T (epirubicin/cyclophosphamide followed by docetaxel) and TCb (docetaxel/carboplatin) neoadjuvant regimens in early TOP2A-normal stage II-III breast cancer. Neoplasma. 2020 Nov;67(6):1409-1415. doi: 10.4149/neo_2020_200130N96. Epub 2020 Jul 13.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Letrozole Plus Low-Dose Metronomic Capecitabine and EC-T in people with Breast Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.
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 2 inclusion and 1 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 25 Apr 2018. 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 China. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective response rate (time frame: 6 month). 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 NCT03507465, 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 25 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.