Ignite Creation Date:
2024-05-06 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05063136
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2021-09-13
Brief Title:
Adjuvant Metronomic Capecitabine Plus Endocrine Therapy for HRHER2- Primary Breast Cancer
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 TEXTSOFT study showed that compared with the traditional 5-year tamoxifen treatment tamoxifen OFS or aromatase inhibitor OFS can further improve the survival of HRHER2- breast cancer patients However for premenopausal BC patients with HRHER2- only 825 tamoxifen plus OFS and 857 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 HRHER2- 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
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 TEXTSOFT study showed that compared with the traditional 5-year tamoxifen treatment tamoxifen OFS or aromatase inhibitor OFS can further improve the survival of HRHER2- breast cancer patients However for premenopausal BC patients with HRHER2- only 825 tamoxifen plus OFS and 857 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 HRHER2- 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 11 ratio The experimental group received 1 year of capecitabine 500mg Tid orallystandard endocrine therapy at least 5 years The control group received 1 year of placebo Tid oralstandard endocrine therapy at least 5 years If an intolerable toxic reaction occurs adjust the drug dosage according to the CTCAE 40 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 weeksClinical suspected recurrence will be determined through additional imaging examinations and should be determined as much as possible through histologycytology unless deemed unsafe based on the researchers judgmentSurvival 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None