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Breast CancerPhase 3SMARTNCT03561740

A Study of the Addition of Metronomic Capecitabine to Standard Adjuvant Therapy in High Risk HER2+ BC paTients

A Phase 3 study testing capecitabine in people with Breast Cancer, run by Sun Yat-sen University 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

Breast cancer is the most common malignant tumor in women. Recurrent or metastatic breast cancer is incurable. High risk patients usually have the following characteristics, such as, non-pCR after neoadjuvant therapy, lymph nodes positive, >2cm tumor size, HER2 overexpression, etc. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Breast Cancer
What is being tested?
capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
794 participants
Where
1 siteChina
Study dates
25 Jul 2018to 31 Dec 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Early stage operable HER2-positive primary breast cancer
  • Histologically confirmed invasive breast carcinoma
  • High risk patients: residual invasive lesions in surgical specimens after neoadjuvant treatment (non-pCR ), Lymph node positive, tumor maximal diameter >2cm. If patient get neoadjuvant treatment, Systemic therapy must consist of at least 6 cycles of chemotherapy, with a total duration at least 16 weeks, including at least 9 weeks of trastuzumab and at least 9 weeks of taxane-based chemotherapy. Patients may have received an anthracycline as part of preoperative therapy in addition to taxane chemotherapy. Patients receiving dose-dense chemotherapy regimens are eligible, provided at least 8 weeks of taxane-based therapy and at least 8 weeks of trastuzumab have been given.
  • Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes
  • Known hormone receptor status
  • Signed written informed consent approved by the study site's Institutional Review Board (IRB)/Ethical Committee (EC)
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  • Age ≥ 18 years, Age ≤ 70 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate organ function during screening, defined as:
  • Absolute neutrophil count ≥ 1200 cells/mm3
  • Platelet count ≥ 100000 cells/mm3
  • Hemoglobin ≥ 9.0 g/dL; patients may receive red blood cell transfusions to obtain this level
  • Serum creatinine 1.5 upper limit of normal (ULN)
  • International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 ULN
  • Serum AST and ALT ≤ 1.5 ULN
  • Serum total bilirubin (TBILI) ≤ 1.0 ULN (within normal limits), except for patients with Gilbert's syndrome, for whom direct bilirubin should be within the normal range
  • Serum alkaline phosphatase (ALK) ≤ 1.5 ULN
  • Screening LVEF ≥ 50% on ECHO or MUGA after receiving neoadjuvant chemotherapy and no decrease in LVEF by more than 15% absolute points from the pre-chemotherapy LVEF. Or, if pre-chemotherapy LVEF was not assessed, the screening LVEF must be ≥ 55% after completion of neoadjuvant chemotherapy.
  • LVEF assessment may be repeated once up to 3 weeks following the initial screening assessment to assess eligibility.
  • For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to remain abstinent or use single or combined contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 7 months after the last dose of study drug.
  • Negative serum pregnancy test for premenopausal women including women who have had a tubal ligation and for women less than 12 months after the onset of menopause
  • Documentation of hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies is required: this includes HB surface antigen (HBsAg) and/or total HB core antibody (anti-HBc) in addition to HCV antibody testing. The most recent serologic testing must have occurred within 3 months prior to initiation of neoadjuvant therapy. If such testing has not been done, it must be performed during screening.

Who cannot join

  • Stage IV (metastatic) breast cancer
  • History of any prior (ipsi- or contralateral) breast cancer except lobular CIS
  • Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery
  • An overall response of PD according to the investigator at the conclusion of preoperative systemic therapy
  • Treatment with any anti-cancer investigational drug within 28 days prior to commencing study treatment
  • History of other malignancy within the last 5 years except for appropriately treated CIS of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above
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  • Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons (e.g., connective tissue disorder or prior ipsilateral breast radiation)
  • Current NCI CTCAE (Version 4.0) Grade ≥ 2 peripheral neuropathy
  • History of exposure to the following cumulative doses of anthracyclines:
  • Doxorubicin >240 mg/m2, Epirubicin or Liposomal Doxorubicin-Hydrochloride (Myocet®) >480 mg/m2 For other anthracyclines, exposure equivalent to doxorubicin >240 mg/m2
  • Cardiopulmonary dysfunction as defined by any of the following:
  • History of NCI CTCAE (Version 4.0) Grade ≥ 3 symptomatic CHF or NYHA criteria Class ≥ II Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease High-risk uncontrolled arrhythmias: i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block (second degree AV-block Type 2 [Mobitz 2] or third degree AV-block) Significant symptoms (Grade ≥ 2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia while or since receiving preoperative therapy.
  • History of a decrease in LVEF to <40% with prior trastuzumab treatment (e.g., during preoperative therapy) Uncontrolled hypertension (systolic blood pressure >180 mmHg and/or diastolic blood pressure >100 mmHg) Evidence of transmural infarction on ECG Requirement for continuous oxygen therapy
  • Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease; wound-healing disorders; ulcers)
  • For female patients, current pregnancy and/or lactation
  • Major surgical procedure unrelated to breast cancer or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment
  • Any known active liver disease, for example, disease due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis. Patients who have positive HBV or HCV serologies without known active disease must meet the eligibility criteria for ALT, AST, TBILI, INR, aPTT, and alkaline phosphatase (ALK) on at least two consecutive occasions, separated by at least 1 week, within the 30 day screening period.
  • Concurrent, serious, uncontrolled infections or known infection with HIV
  • History of intolerance, including Grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins or any components of the product
  • Active, unresolved infections at screening requiring treatment
  • Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol

Trial locations and contacts

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

Shusen Wang, MD contact

+86-13926168469

wangshs@sysucc.org.cn

Wen Xia, MD contact

+86-18565557603

xiawen@sysucc.org.cn

China1 site, 1 recruiting

  • Shusen Wang

    Guangzhou, Guangdong, 510060

    shusen wang, doctor, 13926168469, wangshs@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Multicenter, Open-label Phase III Study to Evaluate the Efficacy and Safety of Adding Metronomic Chemotherapy of Capecitabine to Standard Adjuvant Therapy for Patients With High Risk HER2-positive Primary Breast Cancer

Breast cancer is the most common malignant tumor in women. Recurrent or metastatic breast cancer is incurable. High risk patients usually have the following characteristics, such as, non-pCR after neoadjuvant therapy, lymph nodes positive, >2cm tumor size, HER2 overexpression, etc. Intensive targeted or chemo therapy could improve prognosis. Previous studies have shown the efficacy and feasibility of intensive treatment of capecitabine in non-pCR breast cancer patients. Given the metronomic capecitabine therapy is well tolerated, we designed this study to compare the efficacy and safety of adding metronomic capecitabine to standard adjuvant therapy for high risk HER2+ breast cancer patients.

Conditions
Breast Cancer
Being tested
capecitabine
Keywords
breast cancer, HER2-positive, metronomic chemotherapy, capecitabine, high-risk
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

    Also called Xeloda

    additional metronomic chemotherapy of capecitabine

Study groups in NCT03561740
Study groupRoleWhat they receive
Metronomic Capecitabine GroupExperimentalPatients in experimental group (also Metronomic Capecitabine Group) will receive additional metronomic chemotherapy of capecitabine (500mg TID po), begin after the completion of standard adjuvant chemotherapy or surgery if neoadjuvant chemotherapy were administrated, until three weeks after the last cycle of trastuzumab (6mg/kg every 3 weeks).
Receives: Drug: capecitabine
Control GroupNo interventionPatients in control group will receive standard therapy only, as per the guidelines.

What is being measured

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

  1. Invasive disease-free survival (IDFS)

    Time from randomization to ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death of any cause

    Measured: up to 10 years

Secondary outcomes (5)

  1. Invasive disease-free survival including second non-breast cancers

    Defined the same way as invasive disease-free survival for the primary endpoint but including second primary non-breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ of any site)

    Measured: up to 10 years

  2. Disease-free survival

    Time from randomization to first occurrence of an invasive disease-free survival event including second primary non-breast cancer or contralateral or ipsilateral ductal carcinoma in situ

    Measured: up to 10 years

  3. Overall survival

    Time from randomization to death of any cause

    Measured: up to 10 years

  4. Breast cancer specific survival

    Time from randomization to death of breast cancer

    Measured: up to 10 years

  5. Distant recurrence-free interval

    Time from randomization to date of distant breast cancer recurrence

    Measured: up to 10 years

Timeline

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

  1. First posted19 Jun 2018
  2. Study start25 Jul 2018
  3. Primary completion15 Jun 2023 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
794 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03561740
Sponsor's protocol ID
SCBCG-006
Acronym
SMART
Status last verified
Jul 2018
First submitted
5 May 2018
Last updated
26 Jul 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing capecitabine in people with Breast Cancer, run by Sun Yat-sen University 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 22 inclusion and 21 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 26 Jul 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 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 Shusen Wang, MD (+86-13926168469, wangshs@sysucc.org.cn), 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: up to 10 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 NCT03561740.

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 26 Jul 2018.

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