Breast CancerCALORIENCT03821454
Capecitabine in the Treatment of Breast Cancer With Low-hormone Receptor Expression After Neoadjuvant Chemotherapy
A study testing Capecitabine in people with Breast Cancer, run by Zhejiang Cancer Hospital.
Trial summary
Capecitabine is recommended for adjuvant treatment of advanced or metastatic breast cancer and is particularly effective in patients with triple-negative breast cancer (TNBC). CREATE-X clinical studies have demonstrated that Capecitabine can further improve prognosis and demonstrate good tolerance in patients who have… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2019to 1 Feb 2021
- Phase
- Interventional
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Women and men at least 18 years of age or older.
- Pathological confirmation of breast cancer
- Tumor stage(TNM): T1-4N0-3M0
- No evidence of distant metastasis
- Adequate bone marrow, hepatic, and renal function
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- Measurable disease as per RECIST criteria
- Karnofsky≥70
- Laboratory criteria:
- PLT≥100109/L WBC≥4000/mm3 HGB≥10g/dl ALT and AST<2ULN
Who cannot join
- Presence of metastatic disease.
- Inflammatory breast cancer.
- Bilateral breast cancer.
- Postoperative treatment with other adjuvant chemotherapy drugs.
- Other malignant tumors (concurrent or previous).
- Pregnant woman.
- Hypersensitive to any drug in Capecitabine or any ingredient of Capecitabine.
- Any severe systemic disease contraindicating chemotherapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of Capecitabine in the Treatment of Early-stage Breast Cancer With Low-hormone Receptor Expression and Residual Invasive Carcinoma After Neoadjuvant Chemotherapy
Capecitabine is recommended for adjuvant treatment of advanced or metastatic breast cancer and is particularly effective in patients with triple-negative breast cancer (TNBC).
CREATE-X clinical studies have demonstrated that Capecitabine can further improve prognosis and demonstrate good tolerance in patients who have not achieved pathologic complete response (pCR) after neoadjuvant chemotherapy.
Read more
Previous studies have confirmed that the pathological features of the low- hormone receptor (HR)positive population in breast cancer are similar to those in the TNBC population, with a poor prognosis and are not sensitive to adjuvant endocrine therapy.
We hypothesize that the use of Capecitabine in breast cancer patients with residual invasive carcinoma after neoadjuvant chemotherapy may improve prognosis.
Read the detailed description
The investigators will recruit patients who had low- hormone receptor (HR)positive breast cancer of stage I - IIIC and pathologically assessed residual cancer cells (no pathological complete response, non-pCR) after neoadjuvant chemotherapy with anthracycline, taxane, or both. Participants who have residual components of ductal carcinoma in situ are assessed as having a pathological complete response. Participants with tumor-positive lymph nodes excluded.
Other key eligibility criteria are low- hormone receptor (HR)positive, including low-ER and low-PR, low-ER and PR-negative, low-PR and ER-negative. The definition of low hormone receptor (HR) positive is nuclear staining of 1%-10% of the epithelial component of the tumor.
Eligible participants are centrally enrolled after pathological assessment and are randomly assigned in a 1:1 ratio to receive either capecitabine plus standard therapy or standard therapy alone (control).
The trial treatments are standard postsurgical treatments, which included endocrine therapy in participants with estrogen-receptor-positive (nuclear staining ≥ 1%) disease, targeted therapy in participants with HER-2 overexpression and radiotherapy (if indicated), with or without capecitabine.
After surgery, the capecitabine group receive oral capecitabine (at a dose of 1250 mg per square meter of body-surface area, twice per day, on days 1 to 14) every 3 weeks for eight cycles. The concomitant administration of postsurgical endocrine therapy is allowed. Postsurgical radiotherapy could be given before or after randomization and could be concomitant with postsurgical endocrine therapy.
- Conditions
- Breast Cancer
- Being tested
- Capecitabine, Placebos
- 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
Oral capecitabine (at a dose of 1250 mg per square meter of body-surface area, twice per day, on days 1 to 14) every 3 weeks for eight cycles.
PlacebosDrug
Oral Placebos (twice per day, on days 1 to 14) every 3 weeks for eight cycles.
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine | Experimental | The experimental group received oral capecitabine for eight cycles. Receives: Drug: Capecitabine |
| Placebo | Placebo comparator | The placebo group received oral placebo for eight cycles. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival(DFS)
First Dose of Capecitabine or Placebo to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse.
Measured: Time of Surgery up to 5 years.
Overall Survival(OS)
Time from the first dose of Capecitabine or Placebo to death due to any cause.
Measured: First Dose of Capecitabine or Placebo up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start1 Feb 2019 (estimated)
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2021 (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 Zhejiang 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821454
- Sponsor's protocol ID
- CALORIE
- Acronym
- CALORIE
- Status last verified
- Jan 2019
- First submitted
- 26 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study of Capecitabine in the Treatment of Early-stage Breast Cancer With Low-hormone Receptor Expression and Residual Invasive Carcinoma After Neoadjuvant Chemotherapy
- ClinicalTrials.gov ID
- NCT03821454
- Acronym / sponsor ID
- CALORIE / CALORIE
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 29 Jan 2019 (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.
Capecitabine is recommended for adjuvant treatment of advanced or metastatic breast cancer and is particularly effective in patients with triple-negative breast cancer (TNBC).
CREATE-X clinical studies have demonstrated that Capecitabine can further improve prognosis and demonstrate good tolerance in patients who have not achieved pathologic complete response (pCR) after neoadjuvant chemotherapy.
Previous studies have confirmed that the pathological features of the low- hormone receptor (HR)positive population in breast cancer are similar to those in the TNBC population, with a poor prognosis and are not sensitive to adjuvant endocrine therapy.
We hypothesize that the use of Capecitabine in breast cancer patients with residual invasive carcinoma after neoadjuvant chemotherapy may improve prognosis.
Detailed description
The investigators will recruit patients who had low- hormone receptor (HR)positive breast cancer of stage I - IIIC and pathologically assessed residual cancer cells (no pathological complete response, non-pCR) after neoadjuvant chemotherapy with anthracycline, taxane, or both. Participants who have residual components of ductal carcinoma in situ are assessed as having a pathological complete response. Participants with tumor-positive lymph nodes excluded.
Other key eligibility criteria are low- hormone receptor (HR)positive, including low-ER and low-PR, low-ER and PR-negative, low-PR and ER-negative. The definition of low hormone receptor (HR) positive is nuclear staining of 1%-10% of the epithelial component of the tumor.
Eligible participants are centrally enrolled after pathological assessment and are randomly assigned in a 1:1 ratio to receive either capecitabine plus standard therapy or standard therapy alone (control).
The trial treatments are standard postsurgical treatments, which included endocrine therapy in participants with estrogen-receptor-positive (nuclear staining ≥ 1%) disease, targeted therapy in participants with HER-2 overexpression and radiotherapy (if indicated), with or without capecitabine.
After surgery, the capecitabine group receive oral capecitabine (at a dose of 1250 mg per square meter of body-surface area, twice per day, on days 1 to 14) every 3 weeks for eight cycles. The concomitant administration of postsurgical endocrine therapy is allowed. Postsurgical radiotherapy could be given before or after randomization and could be concomitant with postsurgical endocrine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capecitabine | Experimental | Drug: CapecitabineThe experimental group received oral capecitabine for eight cycles. |
| Placebo | Placebo comparator | Drug: PlacebosThe placebo group received oral placebo for eight cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Provision of informed consent
- Women and men at least 18 years of age or older.
- Pathological confirmation of breast cancer
- Tumor stage(TNM): T1-4N0-3M0
- No evidence of distant metastasis
Key exclusion criteria (8 listed)
- Presence of metastatic disease.
- Inflammatory breast cancer.
- Bilateral breast cancer.
- Postoperative treatment with other adjuvant chemotherapy drugs.
- Other malignant tumors (concurrent or previous).
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 |
|---|---|---|
| CapecitabineOral capecitabine (at a dose of 1250 mg per square meter of body-surface area, twice per day, on days 1 to 14) every 3 weeks for eight cycles. | Drug | Capecitabine |
| PlacebosOral Placebos (twice per day, on days 1 to 14) every 3 weeks for eight cycles. | Drug | Placebo |
Primary outcome
Event Free Survival(DFS)
Time frame: Time of Surgery up to 5 years.
First Dose of Capecitabine or Placebo to first documentation of local or distant recurrence, or death or initiation of antineoplastic therapy before documentation of first relapse.
Overall Survival(OS)
Time frame: First Dose of Capecitabine or Placebo up to 5 years.
Time from the first dose of Capecitabine or Placebo to death due to any cause.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Capecitabine in people with Breast Cancer, run by Zhejiang Cancer Hospital.
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 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: status not confirmed, as of the sponsor's last update on 1 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Ding Xiaowen, DR. (+86 13588054604, dingxw@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Free Survival(DFS) (time frame: Time of Surgery up to 5 years.). The study lists 2 primary outcomes in all. 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 1 Feb 2019.