Breast CancerPhase 2NCT05747326
Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer
A Phase 2 study testing oral vinorelbine and capecitabine in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- oral vinorelbine and capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to Jun 2023
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female;
- aged ≥ 18 years and ≤75 years;
- histologically proved metastatic HER-2 negative breast cancer. HER2-negative status determined by situ hybridization (FISH) or immunohistochemistry (IHC) (IHC 0, 1+, 2+ and/or FISH HER2 negative);
- at least one measurable or evaluable lesion based on RECIST 1.1 criteria;
- estimated life expectancy ≥ 3 months;
- normal heart, liver, and kidney function;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- informed consent signed by the participants
Who cannot join
- received neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine within one year prior to treatment initiation;
- participated in other new drug clinical trials within 4 weeks before enrollment;
- inflammatory breast cancer;
- symptomatic visceral disease;
- second primary malignancy;
- mental disorder.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital
Beijing, Beijing Municipality, 00
Qiao Li, Dr., +8615910573527, liqiaopumc@qq.com
Yue Chai, Dr., 13350804092, cy972628990@163.com
About this study
Official title: A Doublelet Metronomic Chemotherapeutic Regimen With Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer Patients: A Monocentric Retrospective Study in China
This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China.
Read the detailed description
Metronomic chemotherapy is a relatively low-dose, high-frequency, continuous application of cytotoxic agents. Phase I/II VICTOR-1 studies have shown that the dual oral beat combination of vincristine and capecitabine is highly active and well tolerated in patients with locally advanced or metastatic breast cancer. The long-term efficacy of oral two-metronomic agents (vinorelbine and capecitabine) in Chinese advanced HER-2 negative breast cancer patients stays unclear. The current study was designed to explore the efficacy of oral two-metronomic agents (vinorelbine and capecitabine) in advanced HER-2 negative patient China.
- Conditions
- Breast Cancer
- Being tested
- oral vinorelbine and capecitabine
- Keywords
- Breast Cancer, metronomic treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral vinorelbine and capecitabineDrug
Also called metronomic agents (vinorelbine and capecitabine )
The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles. Receives: Drug: oral vinorelbine and capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival
1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Measured: At 1 year
Secondary outcomes (1)
Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better
Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR Confirmed response will be evaluated using all cycles. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Jan 2022
- Primary completion1 Jun 2023 (estimated)
- Study completionJun 2023 (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 Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China. The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Binghe Xu, Study director, National Cancer Center/National Clinical Research Center for Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747326
- Sponsor's protocol ID
- m-VCAP1
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual anonymized participant data will not be shared.
Publications
Chai Y, Liu J, Jiang M, He M, Wang Z, Ma F, Wang J, Yuan P, Luo Y, Xu B, Li Q. A phase II study of a doublet metronomic chemotherapy regimen consisting of oral vinorelbine and capecitabine in Chinese women with HER2-negative metastatic breast cancer. Thorac Cancer. 2023 Aug;14(23):2259-2268. doi: 10.1111/1759-7714.15011. Epub 2023 Jul 4.
PubMed 37402471
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Doublelet Metronomic Chemotherapeutic Regimen With Oral Vinorelbine and Capecitabine in Advanced HER2-negative Breast Cancer Patients: A Monocentric Retrospective Study in China
- ClinicalTrials.gov ID
- NCT05747326
- Acronym / sponsor ID
- m-VCAP1
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, metronomic treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 28 Feb 2023 (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.
This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China.
Detailed description
Metronomic chemotherapy is a relatively low-dose, high-frequency, continuous application of cytotoxic agents. Phase I/II VICTOR-1 studies have shown that the dual oral beat combination of vincristine and capecitabine is highly active and well tolerated in patients with locally advanced or metastatic breast cancer. The long-term efficacy of oral two-metronomic agents (vinorelbine and capecitabine) in Chinese advanced HER-2 negative breast cancer patients stays unclear. The current study was designed to explore the efficacy of oral two-metronomic agents (vinorelbine and capecitabine) in advanced HER-2 negative patient China.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study was a prospective, single-arm, open-label phase II clinical trial conducted at National cancer center in China. The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles.
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: oral vinorelbine and capecitabineThe eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- female;
- aged ≥ 18 years and ≤75 years;
- histologically proved metastatic HER-2 negative breast cancer. HER2-negative status determined by situ hybridization (FISH) or immunohistochemistry (IHC) (IHC 0, 1+, 2+ and/or FISH HER2 negative);
- at least one measurable or evaluable lesion based on RECIST 1.1 criteria;
- estimated life expectancy ≥ 3 months;
Key exclusion criteria (6 listed)
- received neoadjuvant or adjuvant therapy containing vinorelbine or capecitabine within one year prior to treatment initiation;
- participated in other new drug clinical trials within 4 weeks before enrollment;
- inflammatory breast cancer;
- symptomatic visceral disease;
- second primary malignancy;
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 |
|---|---|---|
| oral vinorelbine and capecitabineAlso: metronomic agents (vinorelbine and capecitabine )The eligible patients were enrolled to receive oral metronomic vinorelbine 40 mg on day 1, day 3, day 5 every week (Monday, Wednesday, and Friday) and capecitabine 500mg three times daily (tid) after meals every 3 weeks. Until disease progression or unacceptable toxicity occurred, or the patient refused medication, vinorelbine and capecitabine were administered continuously without drug-free periods over 21-day cycles. | Drug | Study group |
Primary outcome
Progression-free Survival
Time frame: At 1 year
1-year progression-free survival (PFS1). Evidence of local recurrence, distant metastasis, or death from any cause within 1 year counted as events in the time-to-event Kaplan-Meier analysis of progression-free survival. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
1 secondary outcome
Proportion of Confirmed Response, Defined as a Partial Response (PR) or Better
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Derived from this study: PubMed 37402471Chai Y, Liu J, Jiang M, He M, Wang Z, Ma F, Wang J, Yuan P, Luo Y, Xu B, Li Q. A phase II study of a doublet metronomic chemotherapy regimen consisting of oral vinorelbine and capecitabine in Chinese women with HER2-negative metastatic breast cancer. Thorac Cancer. 2023 Aug;14(23):2259-2268. doi: 10.1111/1759-7714.15011. Epub 2023 Jul 4.
- Individual participant dataSharing planned: No. Individual anonymized participant data will not be shared.
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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.
Binghe Xu study director
National Cancer Center/National Clinical Research Center for Cancer
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 oral vinorelbine and capecitabine in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 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: status not confirmed, as of the sponsor's last update on 28 Feb 2023. 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 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 Qiao Li, Dr. (+8615910573527 ext. 87788819, liqiaopumc@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (time frame: At 1 year). 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 NCT05747326, 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 28 Feb 2023.