Breast CancerPhase 3NCT05212454

Efficacy of Supplement Adjuvant Capecitabine in HR+/HER2- Breast Cancer Patients With High Risks

A Phase 3 study testing Capecitabine in people with Breast Cancer and Chemotherapy Effect, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Breast Cancer, Chemotherapy Effect
What is being tested?: Capecitabine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 400 participants
Where: 1 siteChina
Study dates: 15 Mar 2023to Dec 2029
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

Female, age 18-70 years.
Completed radical breast cancer surgery with confirmed pathology suggested primary invasive breast adenocarcinoma, ER and/or PR positive (defined as positive cells >1%) and HER2 negative (defined as HER2 immunohistochemistry 2+ or less and FISH negative).
Definition of high-risk factors: 4 or more positive axillary lymph nodes; 1-3 positive axillary lymph nodes with primary tumor ≥ 5 cm or histologic grade 3 or ki67 ≥ 20%; or residual lesions despite neoadjuvant chemotherapy.
No prior treatment for present breast cancer onset.
ECOG physical status score 0 to 1
Hematological examination before treatment should meet: white blood cell count (WBC) ≥ 4.0×10^9/L, neutrophil count (ANC) ≥ 1.5×10^9/L, platelet count (PLT) ≥ 100×10^9/L; hemoglobin (Hb) ≥ 90g/L; AST (sGOT), ALT (sGPT) ≤ 1.5 times the normal value upper limit, creatinine ≤ 1.5 times the upper limit of normal value, total bilirubin ≤ 1.5 times the upper limit of normal value.
No serious impairment of heart, liver, kidney and other important organ functions.

Who cannot join

Unwilling or unable to use an acceptable method of contraception for up to and including 8 weeks after the final dose of the test drug.
Women during pregnancy and breastfeeding after pregnancy.
Women with proven distant metastases of breast cancer.
Patients with proven sensory or motor nerve disease.
Definite cardiovascular disease, severe co-morbidity or active infection, including known HIV infection.
Patients who need long-term anticoagulant drugs for cardiovascular or thrombotic diseases.
History of other tumors.
Allergic to the study drug or its excipients, etc.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wei Tian, Doctor contact

+86 13777825246

denyiweit@zju.edu.cn

China1 site, 1 recruiting

the Second Affiliated Hospital of Zhejiang Univercity School of Medicine
Hanzhou, Zhejiang
Jianan Wang, Doctor
Weilin Wang, Doctor
Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Supplement Adjuvant Capecitabine in Postoperative Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative High-risk Breast Cancer Patients: a Multicenter, Single-arm Clinical Trial

According to the latest data from the World Health Organization's International Agency for Research on Cancer (IARC) for 2020, breast cancer has been the most prevalent cancer with 2.26 million new cases. Among Chinese breast cancer patients, approximately 60% are hormone receptor (HR) positive, and 80% have early-stage breast cancer. For HR-positive, human epidermal growth factor receptor-2 (HER2) negative breast cancer patients, the first peak of recurrence is about 2-3 years after surgery, especially for patients with high-risk clinical and/or pathological features. Therefore, adjuvant therapy is essential to reduce recurrence during this period.

Capecitabine is an anti-metabolite fluoropyrimidine deoxynucleoside carbamate that can be converted to fluorouracil (5-Fu) in vivo. Studies have shown that patients with HR-positive HER2-negative breast cancer with high-risk factors may benefit from postoperative adjuvant capecitabine therapy as well as patients with triple-negative breast cancer. Therefore, we assumed that additional capecitabine may reduce the reccurence of breast cancer in patients with high-risk factors.

This trial is an open, single-arm clinical trial designed to investigate the effect of additional adjuvant capecitabine therapy on recurrence and survival in HR-positive HER2-negative breast cancer patients with high-risk factors.

Conditions: Breast Cancer, Chemotherapy Effect
Being tested: Capecitabine
Keywords: breast cancer, HR positive HER2 negative, high-risk factors, capecitabine, adjuvant chemotherapy
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
capecitabine, 0.5g per pill, given 1250mg/m2 twice a day for 2 weeks of the 3-week treatment course. The total duration of treatment is 8 courses.

Study groups in NCT05212454
Study group	Role	What they receive
capecitabine group	Experimental	All enrolled cases should be given standard chemotherapy, radiotherapy and endocrine therapy according to the Chinese Society of Clinical Oncology (CSCO) guidelines for the treatment of breast cancer, with the specific regimen decided by the doctor according to the condition. After the completion of standard chemotherapy, capecitabine 1250mg/m2 should be given orally twice a day for 2 weeks of the 3-week treatment course, and the total duration of treatment is 8 courses, which can be given simultaneously with radiotherapy and endocrine therapy. Premenopausal patients may use ovarian suppressants as needed. Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

disease free survival
defined as the time from randomization to recurrence in situ, metastasis, contralateral breast cancer, second primary cancer, and all-cause death.
Measured: 5 years

Secondary outcomes (2)

overall survival
defined as the time from randomizeation to all-cause death
Measured: 5 years
invasive disease free survival
Defined as time from randomization to local or distant recurrence of invasive cancer
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 2023Dec 2029

First posted28 Jan 2022
Study start15 Mar 2023
Primary completionDec 2025 (estimated)
Study completionDec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)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 Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 400 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05212454
Sponsor's protocol ID: 2021-1116
Status last verified: Apr 2023
First submitted: 15 Jan 2022
Last updated: 25 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fan L, Strasser-Weippl K, Li JJ, St Louis J, Finkelstein DM, Yu KD, Chen WQ, Shao ZM, Goss PE. Breast cancer in China. Lancet Oncol. 2014 Jun;15(7):e279-89. doi: 10.1016/S1470-2045(13)70567-9.
PubMed 24872111
Yin W, Di G, Zhou L, Lu J, Liu G, Wu J, Shen K, Han Q, Shen Z, Shao Z. Time-varying pattern of recurrence risk for Chinese breast cancer patients. Breast Cancer Res Treat. 2009 Apr;114(3):527-35. doi: 10.1007/s10549-008-0022-5. Epub 2008 Apr 19.
PubMed 18425576
Mamounas EP, Tang G, Paik S, Baehner FL, Liu Q, Jeong JH, Kim SR, Butler SM, Jamshidian F, Cherbavaz DB, Sing AP, Shak S, Julian TB, Lembersky BC, Lawrence Wickerham D, Costantino JP, Wolmark N. 21-Gene Recurrence Score for prognosis and prediction of taxane benefit after adjuvant chemotherapy plus endocrine therapy: results from NSABP B-28/NRG Oncology. Breast Cancer Res Treat. 2018 Feb;168(1):69-77. doi: 10.1007/s10549-017-4550-8. Epub 2017 Nov 11.
PubMed 29128898
Natori A, Ethier JL, Amir E, Cescon DW. Capecitabine in early breast cancer: A meta-analysis of randomised controlled trials. Eur J Cancer. 2017 May;77:40-47. doi: 10.1016/j.ejca.2017.02.024. Epub 2017 Mar 27.
PubMed 28355581
Walko CM, Lindley C. Capecitabine: a review. Clin Ther. 2005 Jan;27(1):23-44. doi: 10.1016/j.clinthera.2005.01.005.
PubMed 15763604
Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, Kuroi K, Im SA, Park BW, Kim SB, Yanagita Y, Ohno S, Takao S, Aogi K, Iwata H, Jeong J, Kim A, Park KH, Sasano H, Ohashi Y, Toi M. Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. N Engl J Med. 2017 Jun 1;376(22):2147-2159. doi: 10.1056/NEJMoa1612645.
PubMed 28564564
Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Kokko R, Ahlgren J, Auvinen P, Paija O, Helle L, Villman K, Nyandoto P, Nilsson G, Pajunen M, Asola R, Poikonen P, Leinonen M, Kataja V, Bono P, Lindman H. Adjuvant capecitabine, docetaxel, cyclophosphamide, and epirubicin for early breast cancer: final analysis of the randomized FinXX trial. J Clin Oncol. 2012 Jan 1;30(1):11-8. doi: 10.1200/JCO.2011.35.4639. Epub 2011 Nov 21.
PubMed 22105826

Interested in taking part?

Wei Tian, Doctor

+86 13777825246

denyiweit@zju.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
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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

All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Supplement Adjuvant Capecitabine in Postoperative Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative High-risk Breast Cancer Patients: a Multicenter, Single-arm Clinical Trial
ClinicalTrials.gov ID: NCT05212454
Acronym / sponsor ID: 2021-1116
Conditions: Breast Cancer, Chemotherapy Effect
Keywords: breast cancer, HR positive HER2 negative, high-risk factors, capecitabine, adjuvant chemotherapy
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 400 participants (estimated)
Lead sponsor: Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
Study start: 15 Mar 2023 (actual)
Primary completion: Dec 2025 (estimated)
Study completion: Dec 2029 (estimated)
First posted: 28 Jan 2022 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
capecitabine group	Experimental	Drug: CapecitabineAll enrolled cases should be given standard chemotherapy, radiotherapy and endocrine therapy according to the Chinese Society of Clinical Oncology (CSCO) guidelines for the treatment of breast cancer, with the specific regimen decided by the doctor according to the condition. After the completion of standard chemotherapy, capecitabine 1250mg/m2 should be given orally twice a day for 2 weeks of the 3-week treatment course, and the total duration of treatment is 8 courses, which can be given simultaneously with radiotherapy and endocrine therapy. Premenopausal patients may use ovarian suppressants as needed.

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Female, age 18-70 years.
Completed radical breast cancer surgery with confirmed pathology suggested primary invasive breast adenocarcinoma, ER and/or PR positive (defined as positive cells >1%) and HER2 negative (defined as HER2 immunohistochemistry 2+ or less and FISH negative).
Definition of high-risk factors: 4 or more positive axillary lymph nodes; 1-3 positive axillary lymph nodes with primary tumor ≥ 5 cm or histologic grade 3 or ki67 ≥ 20%; or residual lesions despite neoadjuvant chemotherapy.
No prior treatment for present breast cancer onset.
ECOG physical status score 0 to 1

Key exclusion criteria (8 listed)

Unwilling or unable to use an acceptable method of contraception for up to and including 8 weeks after the final dose of the test drug.
Women during pregnancy and breastfeeding after pregnancy.
Women with proven distant metastases of breast cancer.
Patients with proven sensory or motor nerve disease.
Definite cardiovascular disease, severe co-morbidity or active infection, including known HIV infection.

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
Capecitabinecapecitabine, 0.5g per pill, given 1250mg/m2 twice a day for 2 weeks of the 3-week treatment course. The total duration of treatment is 8 courses.	Drug	capecitabine group

Primary outcome

disease free survival
Time frame: 5 years
defined as the time from randomization to recurrence in situ, metastasis, contralateral breast cancer, second primary cancer, and all-cause death.

2 secondary outcomes

overall survival
Time frame: 5 years
invasive disease free survival
Time frame: 5 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 25 Apr 2023.
Background: PubMed 24872111Fan L, Strasser-Weippl K, Li JJ, St Louis J, Finkelstein DM, Yu KD, Chen WQ, Shao ZM, Goss PE. Breast cancer in China. Lancet Oncol. 2014 Jun;15(7):e279-89. doi: 10.1016/S1470-2045(13)70567-9.
Background: PubMed 18425576Yin W, Di G, Zhou L, Lu J, Liu G, Wu J, Shen K, Han Q, Shen Z, Shao Z. Time-varying pattern of recurrence risk for Chinese breast cancer patients. Breast Cancer Res Treat. 2009 Apr;114(3):527-35. doi: 10.1007/s10549-008-0022-5. Epub 2008 Apr 19.
Background: PubMed 29128898Mamounas EP, Tang G, Paik S, Baehner FL, Liu Q, Jeong JH, Kim SR, Butler SM, Jamshidian F, Cherbavaz DB, Sing AP, Shak S, Julian TB, Lembersky BC, Lawrence Wickerham D, Costantino JP, Wolmark N. 21-Gene Recurrence Score for prognosis and prediction of taxane benefit after adjuvant chemotherapy plus endocrine therapy: results from NSABP B-28/NRG Oncology. Breast Cancer Res Treat. 2018 Feb;168(1):69-77. doi: 10.1007/s10549-017-4550-8. Epub 2017 Nov 11.
Background: PubMed 28355581Natori A, Ethier JL, Amir E, Cescon DW. Capecitabine in early breast cancer: A meta-analysis of randomised controlled trials. Eur J Cancer. 2017 May;77:40-47. doi: 10.1016/j.ejca.2017.02.024. Epub 2017 Mar 27.
Background: PubMed 15763604Walko CM, Lindley C. Capecitabine: a review. Clin Ther. 2005 Jan;27(1):23-44. doi: 10.1016/j.clinthera.2005.01.005.
Background: PubMed 28564564Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, Kuroi K, Im SA, Park BW, Kim SB, Yanagita Y, Ohno S, Takao S, Aogi K, Iwata H, Jeong J, Kim A, Park KH, Sasano H, Ohashi Y, Toi M. Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy. N Engl J Med. 2017 Jun 1;376(22):2147-2159. doi: 10.1056/NEJMoa1612645.
Background: PubMed 22105826Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Kokko R, Ahlgren J, Auvinen P, Paija O, Helle L, Villman K, Nyandoto P, Nilsson G, Pajunen M, Asola R, Poikonen P, Leinonen M, Kataja V, Bono P, Lindman H. Adjuvant capecitabine, docetaxel, cyclophosphamide, and epirubicin for early breast cancer: final analysis of the randomized FinXX trial. J Clin Oncol. 2012 Jan 1;30(1):11-8. doi: 10.1200/JCO.2011.35.4639. Epub 2011 Nov 21.
Individual participant dataSharing planned: No

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.

Wei Tian, Doctor contact

+86 13777825246

denyiweit@zju.edu.cn

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 in people with Breast Cancer and Chemotherapy Effect, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 7 inclusion and 8 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 25 Apr 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 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 Wei Tian, Doctor (+86 13777825246, denyiweit@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease free survival (time frame: 5 years). 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 NCT05212454, which also lists 7 linked publications.

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 2023.