Breast CancerPhase 3NCT05063136
Adjuvant Metronomic Capecitabine Plus Endocrine Therapy for HR+/HER2- Primary Breast Cancer
A Phase 3 study testing Capecitabine+endocrine therapy in people with Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Breast cancer (BC) is one of most prevalent malignant tumors in the world. According to the 2020 edition of the global cancer statistics report, the incidence rate of BC has overtaken lung cancer to become the most commonly diagnosed cancer. 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?
- Capecitabine+endocrine therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,979 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2021to Sep 2028
- Phase
- Phase 3
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70 years old
- Women with known menstrual status (at the beginning of randomization or adjuvant endocrine therapy). Postmenopausal status is defined as (1) The patient has undergone bilateral ovariectomy, or (2) Age ≥ 60 years, or age < 60 years, amenorrhea for 12 months or more (without chemotherapy, tamoxifen, toremifene or ovarian suppression), and follicle stimulating hormone (FSH) and plasma estradiol are within the normal range of local postmenopausal women.(3) If the patient is taking tamoxifen or toremifene and is younger than 60 years old, the FSH and plasma estradiol levels are within the postmenopausal range (Notes:For premenopausal women before the start of adjuvant chemotherapy, amenorrhea is not a reliable indicator of menopausal status. Ovarian function may be complete or restored despite anovulation/amenorrhea. For women with treatment-induced amenorrhea, continuous measurements of FSH and/or estradiol are required according to clinical guidelines to determine postmenopausal status.)
- Invasive breast cancer patients with HR (+) and HER2(-), which is confirmed by histopathology. (1) ER and/or PR positive (positive staining accounted for more than 1% of all tumor cells) (2) HER-2 negative (IHC 0, 1+, or IHC 2 + and no fish amplification)
- Patients received radical surgery and chemotherapy (neoadjuvant or adjuvant chemotherapy), and for patients who received neoadjuvant chemotherapy, at least one of the following conditions should be met: (1) Patients not achieving PCR after neoadjuvant chemotherapy; (2) Axillary lymph nodes metastasis (including micro-metastasis) were confirmed by cytology or histology before neoadjuvant chemotherapy.
- Patients who have received breast cancer treatment in the past should meet the following conditions at the same time: (1) No more than 1 year after radical mastectomy. (2) For the patients receiving adjuvant chemotherapy, the time from the last chemotherapy to the beginning of enrollment should be more than 21 days. (3) For patients receiving radiotherapy, it should be no less than 14 days from the date of last radiotherapy to the beginning of enrollment. (4) Endocrine therapy should not exceed 6 months before entering the study (calculated as 30 days per month);
- The following laboratory results should be met to determine that the patient has sufficient bone marrow and organ function: Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet ≥ 100 × 109/L; hemoglobin ≥ 9.0 g / dl; Creatinine clearance rate ≥ 50ml/min; alanine aminotransferase (ALT)< 2.5 × Upper limit of normal range (ULN); aspartate aminotransferase (AST) < 2.5 × ULN.
Show all 10Show fewer
- For patients receiving anthracycline chemotherapy, EF value of cardiac ultrasound was ≥ 55% within 14 days before randomization;
- If the patient is a woman of childbearing age, the serum pregnancy test was negative within 14 days before randomization.
- ECOG score was 0 or 1.
- Patient has signed informed consent voluntarily.
Who cannot join
- Double primary cancers in active stage (simultaneous double primary cancers and heterochronous double primary cancers with disease-free interval ≤ 5 years). Note: carcinoma in situ (intraepithelial carcinoma or lesion equivalent to mucosal carcinoma) cured by local treatment is not included in active double primary carcinoma.
- Bilateral breast cancer (simultaneous/metachronous) (Notes: patients with invasive breast cancer combined with contralateral DCIS, the patient was considered eligible for inclusion if the contralateral DCIS have been removed with radical surgery)
- Received oral 5-FU for more than 2 weeks before treatment (Notes: patient with a history of intravenous 5-FU was considered eligible for inclusion).
- Severe Diarrhea.
- Combined with the following serious complications: (1) Uncontrolled diabetes; (2) Uncontrolled hypertension; (3) Unstable angina and arrhythmias need treatment; (4) cirrhosis and liver failure (5) Interstitial pneumonia, pulmonary fibrosis and severe emphysema; (6) Active infection; (7) Other serious complications.
- Past medical history: (1) myocardial infarction within 6 months; (2) Interstitial pneumonia (For local interstitial pneumonia, it can be proved to improve after treatment. Not included in this definition). (3) History of fluorouracil allergy; (4) Pregnant and lactating women; (5) Other patients not suitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Henan cancer hospital
Zhengzhou, Henan
Zhenzhen Liu, 17729798130, liuzhenzhen73@126.com
About this study
Official title: Adjuvant Capecitabine Metronomic Chemotherapy Plus Endocrine Therapy for HR-positive, HER2-negative, Primary Breast Cancer: a Multicenter, Randomized, Double-blind Phase III Clinical Trial
Breast cancer (BC) is one of most prevalent malignant tumors in the world. According to the 2020 edition of the global cancer statistics report, the incidence rate of BC has overtaken lung cancer to become the most commonly diagnosed cancer.
In the past three decades, survival of patients with primary BC have been notably improved, mainly due to early detection of the disease and advances in adjuvant treatments such as endocrine therapy, chemotherapy, and anti-HER2 therapy. Patients with HR-positive and HER2-negative primary BC account for approximately 70% of all cases of early breast cancer. Endocrine therapy is the core treatment for this subtype of BC. Tamoxifen, aromatase inhibitor or their sequential administration can reduce the recurrence and mortality of this BC subtype.
Read more
The results of TEXT/SOFT study showed that, compared with the traditional 5-year tamoxifen treatment, tamoxifen + OFS or aromatase inhibitor + OFS can further improve the survival of HR+/HER2- breast cancer patients. However, for premenopausal BC patients with HR+/HER2-, only 82.5% (tamoxifen plus OFS) and 85.7% (aromatase inhibitor plus OFS) of 5-year DFS were achieved. For postmenopausal BC patients, the 5-year DFS was only about 84% with aromatase inhibitors. Therefore, the survival of HR+/ HER2- BC patients needs to be further improved.
Metronomic chemotherapy refers to the use of the minimum effective dose of chemotherapy drugs for long-term, uninterrupted administration to achieve anti-tumor effect. Metronomic chemotherapy has gradually been verified in clinical practice in the past 20 years. In 2020, SYSUCC-001 study has confirmed that capecitabine (650 mg/ m2 bid, for 1 years) can reduce the risk of 5-year DFS events by 36% in TNBC patients in addition to standard treatment. Besides, POTENT study has confirmed that the combination of endocrine therapy and S-1 (for one year) can further reduce the risk of iDFS by 37% in HR+/HER2- BC patients who have completed the standard treatment.
Compared with capecitabine, S-1 has no indication for BC and it is not in the recommendation for BC treatment in the guidelines. Therefore, the investigators conduct this study to explore whether adjuvant Capecitabine metronomic chemotherapy for one year can further improve the survival of BC patients with HR+/ HER2- in addition to standard treatment.
Read the detailed description
In order to evaluate the efficacy and safety of capecitabine combined with endocrine therapy in the adjuvant treatment of hormone receptor positive and HER2 negative women with breast cancer, our center launched a multicenter, randomized, double-blind phase III clinical trial of capecitabine combined with endocrine therapy in the adjuvant treatment of hormone receptor positive and HER2 negative women with breast cancer. Select suitable patients for inclusion based on the inclusion criteria. The enrolled patients were randomly assigned to the experimental group and control group in a 1:1 ratio. The experimental group received 1 year of capecitabine (500mg Tid orally)+standard endocrine therapy (at least 5 years); The control group received 1 year of placebo (Tid oral)+standard endocrine therapy (at least 5 years). If an intolerable toxic reaction occurs, adjust the drug dosage according to the CTCAE 4.0 principles for managing adverse drug reactions, but still cannot tolerate it, stop chemotherapy. The primary end point of efficacy evaluation of iDFS included detection of local recurrence, distant recurrence, ipsilateral and contralateral invasive breast cancer, the second primary invasive non breast cancer, and death. During the first 24 months (30 days per month, the same below) after random grouping, clinical recurrence event assessments will be conducted every 3 months (± 2 weeks). Subsequently, an evaluation will be conducted every 6 months (± 3 weeks).Clinical suspected recurrence will be determined through additional imaging examinations, and should be determined as much as possible through histology/cytology (unless deemed unsafe based on the researcher's judgment).Survival assessment will continue until 60 months after randomization of the last patient, death, withdrawal from informed consent, loss to follow-up, or end of the study, depending on which situation occurs first. Survival information can be obtained through clinical visits, phone calls, or other means.
- Conditions
- Breast Cancer
- Being tested
- Capecitabine+endocrine therapy, Placebo+endocrine therapy
- Keywords
- HR-positive, Her2-negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine+endocrine therapyDrug
Also called Experimental group
Capecitabine (500mg, tid) (for 1 year)+ standard endocrine therapy (at least 5 years)
Placebo+endocrine therapyDrug
Also called Control group
Placebo (tid) (for 1 year)+ standard endocrine therapy (at least 5 years)
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine+endocrine therapy | Experimental | capecitabine (500mg, tid) (for 1 year)+standard endocrine therapy (at least 5 years) Receives: Drug: Capecitabine+endocrine therapy |
| Placebo+endocrine therapy | Placebo comparator | oral placebo (tid) (for 1 year) + standard endocrine therapy (at least 5 years) Receives: Drug: Placebo+endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive disease-free survival (iDFS)
iDFS defined as the period from the treatment allocation date to the confirmed recurrence date (excluding non-invasive ductal carcinoma, non-invasive lobular carcinoma, and all other intraepithelial carcinoma), confirmed development of cancerous lesions other than recurrence, or the date of death from any cause, whichever was the earliest.
Measured: through study completion，an average of 5 year
Secondary outcomes (4)
Overall survival (OS)
OS: defined as the period from the date of allocation to the date of death from any cause
Measured: through study completion，an average of 5 year
Distant disease-free survival (DDFS)
DDFS defined as the period from the date of allocation to the date on which the patient was diagnosed with distant recurrence, or the date of death from any cause
Measured: through study completion，an average of 5 year
Disease-free survival (DFS)
DFS defined as the period from the date of treatment allocation to the date on which recurrence was confirmed, the date on which the development of cancerous lesions other than recurrence was confirmed, or the date of death from any cause, whichever was the earliest
Measured: through study completion，an average of 5 year
Adverse events
The incidence and severity of adverse events will be evaluated according to CTCAE 4.0
Measured: through study completion，up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start28 Sep 2021
- Primary completionSep 2025 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,979 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
- Investigators
- Zhenzhen Liu, Principal investigator, Study Principal Investigator Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063136
- Sponsor's protocol ID
- HELEN-008
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2021
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Capecitabine Metronomic Chemotherapy Plus Endocrine Therapy for HR-positive, HER2-negative, Primary Breast Cancer: a Multicenter, Randomized, Double-blind Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT05063136
- Acronym / sponsor ID
- HELEN-008
- Conditions
- Breast Cancer
- Keywords
- HR-positive, Her2-negative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,979 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Sep 2021 (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.
Breast cancer (BC) is one of most prevalent malignant tumors in the world. According to the 2020 edition of the global cancer statistics report, the incidence rate of BC has overtaken lung cancer to become the most commonly diagnosed cancer.
In the past three decades, survival of patients with primary BC have been notably improved, mainly due to early detection of the disease and advances in adjuvant treatments such as endocrine therapy, chemotherapy, and anti-HER2 therapy. Patients with HR-positive and HER2-negative primary BC account for approximately 70% of all cases of early breast cancer. Endocrine therapy is the core treatment for this subtype of BC. Tamoxifen, aromatase inhibitor or their sequential administration can reduce the recurrence and mortality of this BC subtype.
The results of TEXT/SOFT study showed that, compared with the traditional 5-year tamoxifen treatment, tamoxifen + OFS or aromatase inhibitor + OFS can further improve the survival of HR+/HER2- breast cancer patients. However, for premenopausal BC patients with HR+/HER2-, only 82.5% (tamoxifen plus OFS) and 85.7% (aromatase inhibitor plus OFS) of 5-year DFS were achieved. For postmenopausal BC patients, the 5-year DFS was only about 84% with aromatase inhibitors. Therefore, the survival of HR+/ HER2- BC patients needs to be further improved.
Metronomic chemotherapy refers to the use of the minimum effective dose of chemotherapy drugs for long-term, uninterrupted administration to achieve anti-tumor effect. Metronomic chemotherapy has gradually been verified in clinical practice in the past 20 years. In 2020, SYSUCC-001 study has confirmed that capecitabine (650 mg/ m2 bid, for 1 years) can reduce the risk of 5-year DFS events by 36% in TNBC patients in addition to standard treatment. Besides, POTENT study has confirmed that the combination of endocrine therapy and S-1 (for one year) can further reduce the risk of iDFS by 37% in HR+/HER2- BC patients who have completed the standard treatment.
Compared with capecitabine, S-1 has no indication for BC and it is not in the recommendation for BC treatment in the guidelines. Therefore, the investigators conduct this study to explore whether adjuvant Capecitabine metronomic chemotherapy for one year can further improve the survival of BC patients with HR+/ HER2- in addition to standard treatment.
Detailed description
In order to evaluate the efficacy and safety of capecitabine combined with endocrine therapy in the adjuvant treatment of hormone receptor positive and HER2 negative women with breast cancer, our center launched a multicenter, randomized, double-blind phase III clinical trial of capecitabine combined with endocrine therapy in the adjuvant treatment of hormone receptor positive and HER2 negative women with breast cancer. Select suitable patients for inclusion based on the inclusion criteria. The enrolled patients were randomly assigned to the experimental group and control group in a 1:1 ratio. The experimental group received 1 year of capecitabine (500mg Tid orally)+standard endocrine therapy (at least 5 years); The control group received 1 year of placebo (Tid oral)+standard endocrine therapy (at least 5 years). If an intolerable toxic reaction occurs, adjust the drug dosage according to the CTCAE 4.0 principles for managing adverse drug reactions, but still cannot tolerate it, stop chemotherapy. The primary end point of efficacy evaluation of iDFS included detection of local recurrence, distant recurrence, ipsilateral and contralateral invasive breast cancer, the second primary invasive non breast cancer, and death. During the first 24 months (30 days per month, the same below) after random grouping, clinical recurrence event assessments will be conducted every 3 months (± 2 weeks). Subsequently, an evaluation will be conducted every 6 months (± 3 weeks).Clinical suspected recurrence will be determined through additional imaging examinations, and should be determined as much as possible through histology/cytology (unless deemed unsafe based on the researcher's judgment).Survival assessment will continue until 60 months after randomization of the last patient, death, withdrawal from informed consent, loss to follow-up, or end of the study, depending on which situation occurs first. Survival information can be obtained through clinical visits, phone calls, or other means.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine+endocrine therapy | Experimental | Drug: Capecitabine+endocrine therapycapecitabine (500mg, tid) (for 1 year)+standard endocrine therapy (at least 5 years) |
| Placebo+endocrine therapy | Placebo comparator | Drug: Placebo+endocrine therapyoral placebo (tid) (for 1 year) + standard endocrine therapy (at least 5 years) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18-70 years old
- Women with known menstrual status (at the beginning of randomization or adjuvant endocrine therapy). Postmenopausal status is defined as (1) The patient has undergone bilateral ovariectomy, or (2) Age ≥ 60 years, or age < 60 years, amenorrhea for 12 months or more (without chemotherapy, tamoxifen, toremifene or ovarian suppression), and follicle stimulating hormone (FSH) and plasma estradiol are within the normal range of local postmenopausal women.(3) If the patient is taking tamoxifen or toremifene and is younger than 60 years old, the FSH and plasma estradiol levels are within the postmenopausal range (Notes:For premenopausal women before the start of adjuvant chemotherapy, amenorrhea is not a reliable indicator of menopausal status. Ovarian function may be complete or restored despite anovulation/amenorrhea. For women with treatment-induced amenorrhea, continuous measurements of FSH and/or estradiol are required according to clinical guidelines to determine postmenopausal status.)
- Invasive breast cancer patients with HR (+) and HER2(-), which is confirmed by histopathology. (1) ER and/or PR positive (positive staining accounted for more than 1% of all tumor cells) (2) HER-2 negative (IHC 0, 1+, or IHC 2 + and no fish amplification)
- Patients received radical surgery and chemotherapy (neoadjuvant or adjuvant chemotherapy), and for patients who received neoadjuvant chemotherapy, at least one of the following conditions should be met: (1) Patients not achieving PCR after neoadjuvant chemotherapy; (2) Axillary lymph nodes metastasis (including micro-metastasis) were confirmed by cytology or histology before neoadjuvant chemotherapy.
- Patients who have received breast cancer treatment in the past should meet the following conditions at the same time: (1) No more than 1 year after radical mastectomy. (2) For the patients receiving adjuvant chemotherapy, the time from the last chemotherapy to the beginning of enrollment should be more than 21 days. (3) For patients receiving radiotherapy, it should be no less than 14 days from the date of last radiotherapy to the beginning of enrollment. (4) Endocrine therapy should not exceed 6 months before entering the study (calculated as 30 days per month);
Key exclusion criteria (6 listed)
- Double primary cancers in active stage (simultaneous double primary cancers and heterochronous double primary cancers with disease-free interval ≤ 5 years). Note: carcinoma in situ (intraepithelial carcinoma or lesion equivalent to mucosal carcinoma) cured by local treatment is not included in active double primary carcinoma.
- Bilateral breast cancer (simultaneous/metachronous) (Notes: patients with invasive breast cancer combined with contralateral DCIS, the patient was considered eligible for inclusion if the contralateral DCIS have been removed with radical surgery)
- Received oral 5-FU for more than 2 weeks before treatment (Notes: patient with a history of intravenous 5-FU was considered eligible for inclusion).
- Severe Diarrhea.
- Combined with the following serious complications: (1) Uncontrolled diabetes; (2) Uncontrolled hypertension; (3) Unstable angina and arrhythmias need treatment; (4) cirrhosis and liver failure (5) Interstitial pneumonia, pulmonary fibrosis and severe emphysema; (6) Active infection; (7) Other serious complications.
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 |
|---|---|---|
| Capecitabine+endocrine therapyAlso: Experimental groupCapecitabine (500mg, tid) (for 1 year)+ standard endocrine therapy (at least 5 years) | Drug | Capecitabine+endocrine therapy |
| Placebo+endocrine therapyAlso: Control groupPlacebo (tid) (for 1 year)+ standard endocrine therapy (at least 5 years) | Drug | Placebo+endocrine therapy |
Primary outcome
Invasive disease-free survival (iDFS)
Time frame: through study completion，an average of 5 year
iDFS defined as the period from the treatment allocation date to the confirmed recurrence date (excluding non-invasive ductal carcinoma, non-invasive lobular carcinoma, and all other intraepithelial carcinoma), confirmed development of cancerous lesions other than recurrence, or the date of death from any cause, whichever was the earliest.
4 secondary outcomes
Overall survival (OS)
Time frame: through study completion，an average of 5 year
Distant disease-free survival (DDFS)
Time frame: through study completion，an average of 5 year
Disease-free survival (DFS)
Time frame: through study completion，an average of 5 year
Adverse events
Time frame: through study completion，up to 7 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 4 Nov 2024.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Zhenzhen Liu principal investigator
Study Principal Investigator Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine+endocrine therapy in people with Breast Cancer, run by Henan Cancer 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 10 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: looking for participants now, as of the sponsor's last update on 4 Nov 2024. 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. Some participants in this study may receive a placebo. 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 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?
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 Zhenzhen Liu (13603862755, liuzhenzhen73@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive disease-free survival (iDFS) (time frame: through study completion，an average of 5 year). 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 4 Nov 2024.