Breast Cancer MetastaticPhase 2METRO-ABCNCT02664103
Study of Capecitabine and Cyclophosphamide Administered as a Single Pill in Patients With Advanced Breast Cancer
A Phase 2 study testing Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 in people with Breast Cancer Metastatic, run by Sanofi at 5 sites in India.
Trial summary
Primary Objectives: To assess the safety for each cohort of patients on a fixed-dose combination pill of capecitabine and cyclophosphamide administered at flat dose and with metronomic schedule (defined as continuous daily treatment without interruption) in patients with metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer Metastatic
- What is being tested?
- Fixed-dose combination of capecitabine and cyclophosphamide SAR439281
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 5 sitesIndia
- Study dates
- 23 Jan 2016to 6 Nov 2017
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ≥18 and ≤65 years old.
- Patients with histologically or cytologically confirmed Metastatic Breast Cancer (HER2 negative, ER/PR positive or negative), who are candidates to receive capecitabine and cyclophosphamide as per Investigator's judgment, and meet either one of the following characteristics:
- Recurrence of the disease following at least 2 lines of chemotherapy failure for metastatic triple negative breast cancer.
- In ER/PR positive breast cancer, recurrence of the disease following at least 1 line of chemotherapy failure and 2 lines of hormonal therapy failure.
- Patients who have been previously treated with capecitabine can be recruited in the study provided:
- As per the Investigator's opinion, patients will benefit from this chemotherapy AND
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- For prior single administration of capecitabine: at least 6 months has elapsed between last capecitabine treatment and initiation of study treatment.
- For prior capecitabine-based combination regimen: at least 12 months has elapsed between last capecitabine-based treatment and initiation of study treatment.
- At least one unidimensionally measurable lesion according to RECIST criteria version 1.1.
- An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2.
- Life expectancy of >3 months.
- Patients who are willing to undergo (oral) chemotherapy for the treatment of their disease and who are expected to comply with the treatment and study procedures, as per the Investigator's judgment.
- For women of child bearing potential, documented negative pregnancy test and agreement to use acceptable birth control measures during the duration of the study.
- Signed Informed consent obtained prior to any study related procedures.
Who cannot join
- Patients who are HER 2 positive.
- Patients with 3 or more lines of chemotherapy failure for metastatic triple negative breast cancer.
- In ER/PR positive breast cancer, recurrence of the disease following 2 or more lines of chemotherapy failure and/or 3 or more lines of hormonal therapy failure.
- Patients presenting with de novo stage IV metastatic breast cancer, not previously treated for their disease.
- Patients who have already received any metronomic chemotherapy regimen.
- Known hypersensitivity to capecitabine or to any of its components.
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- Known hypersensitivity to 5-fluorouracil.
- Known hypersensitivity to cyclophosphamide or any of its components.
- History of bladder carcinoma.
- Systemic anticancer therapy (chemotherapy, hormone therapy, or radiotherapy) within 4 weeks of randomization for the study.
- History of unexplained hematuria.
- History of dihydropyrimidine dehydrogenase (DPD) deficiency.
- Severe renal impairment (creatinine clearance below 30 mL/min [Cockroft and Gault]).
- Concomitant warfarin treatment.
- History of significant cardiac disease (eg, unstable angina, congestive heart failure, myocardial infarction, ventricular arrhythmias) within the previous 6 months.
- Conditions/situations such as:
- Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, Study coordinator, other staff, or relative thereof, directly involved in the conduct of the protocol.
- Uncooperative Patient or any condition that could make the Patient potentially noncompliant to the study procedures.
- Pregnant or breast-feeding women.
- Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy.
- Patients with a possibility of active tuberculosis as suggested by:
- Any signs or symptoms suggestive of active tuberculosis upon medical history or clinical examination.
- Chest radiograph within 3 months prior to the screening visit consistent with tuberculosis infection.
- Patients with close contact with a person with active tuberculosis.
- Known history of Human Immunodeficiency Virus (HIV).
- Any other significant medical conditions which in the judgment of the Investigator would preclude completion of the study.
- Participation in a clinical research study evaluating another investigational drug or therapy within 30 days prior to the Screening Visit.
- Presence of any of the following laboratory abnormalities at the Screening Visit:
- Hemoglobin <8.5 g/L;
- White blood cell (WBC) <3000/μL;
- Platelet count <100 000/μL;
- Absolute neutrophil count (ANC) <1500/μL;
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN) (or > 5 x ULN in patients with liver metastasis);
- Total Bilirubin >1.5 X ULN (or > 2 x ULN in patients with liver metastasis).
- Patients with a body surface area (BSA) <1.0 m² or 1.8 m².
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
India5 sites
Investigational Site Number 356009
Kollkata, 700053
Investigational Site Number 356002
Mumbai, 400012
Investigational Site Number 356007
New Delhi, 110085
Investigational Site Number 356008
Trivandrum, 695011
Investigational Site Number 356001
Vellore, 632004
About this study
Official title: A Phase II Open-label Randomized Study of a Fixed-dose Combination of Capecitabine and Cyclophosphamide Administered at Different Doses/Regimens With Metronomic Schedule in Patients With Metastatic Breast Cancer
Primary Objectives:
- To assess the safety for each cohort of patients on a fixed-dose combination pill of capecitabine and cyclophosphamide administered at flat dose and with metronomic schedule (defined as continuous daily treatment without interruption) in patients with metastatic breast cancer.
- To assess the pharmacokinetics (PKs) and bioavailability of the fixed-dose combination pill of capecitabine and cyclophosphamide administered at different doses/regimens by metronomic schedule in patients with metastatic breast cancer.
Read more
Secondary Objectives:
- To assess antitumor activity of the fixed-dose combination pill of capecitabine and cyclophosphamide administered at different doses/regimens by metronomic schedule in patients with metastatic breast cancer given at 3 different doses and schedules (regimen 1=standard dose twice daily [BID], regimen 2=full dose once daily [OD], regimen 3=low dose [OD])
- Disease Control Rate (DCR)
- Overall Response Rate (ORR)
- Time to Progression (TTP) using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1).
- To evaluate the compliance under treatment.
- To describe evolution of toxicities.
- To assess safety all along patient's treatment.
Read the detailed description
Primary objective will be evaluated at 12 weeks. Patients who show evidence of efficacy will be treated and followed-up until progression of the disease.
- Conditions
- Breast Cancer Metastatic
- Being tested
- Fixed-dose combination of capecitabine and cyclophosphamide SAR439281
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed-dose combination of capecitabine and cyclophosphamide SAR439281Drug
Pharmaceutical form:Tablet Route of administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| SAR439281(Cohort 1) | Experimental | Regimen 1: one full-dose tablet containing capecitabine and cyclophosphamide, given BID without interruption Receives: Drug: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 |
| SAR439281(Cohort 2) | Experimental | Regimen 2: two tablets containing capecitabine and cyclophosphamide, given OD without interruption Receives: Drug: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 |
| SAR439281(Cohort 3) | Experimental | Regimen 3: one tablet containing capecitabine and cyclophosphamide, given OD without interruption Receives: Drug: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with adverse events
Measured: 12 weeks
Assessment of PK parameter: maximum concentration (Cmax)
Measured: Daily 12 weeks
Assessment of PK parameter: time to reach Cmax (Tmax)
Measured: Daily 12 weeks
Secondary outcomes (4)
Disease Control Rate (DCR)
Measured: 12 weeks
Objective Response Rate (ORR)
Measured: 12 weeks
Time to Progression (TTP)
Measured: 12 weeks
Proportion of patients compliant with treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study start23 Jan 2016
- Primary completion6 Nov 2017
- Study completion6 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664103
- Sponsor's protocol ID
- CAPCYR07568
- Other IDs
- U1111-1166-1149
- Acronym
- METRO-ABC
- Status last verified
- Jan 2018
- First submitted
- 15 Jan 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-label Randomized Study of a Fixed-dose Combination of Capecitabine and Cyclophosphamide Administered at Different Doses/Regimens With Metronomic Schedule in Patients With Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02664103
- Acronym / sponsor ID
- METRO-ABC / CAPCYR07568
- Conditions
- Breast Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2016 (actual)
- Primary completion
- 6 Nov 2017 (actual)
- Study completion
- 6 Nov 2017 (actual)
- First posted
- 26 Jan 2016 (estimated)
- 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.
Primary Objectives:
- To assess the safety for each cohort of patients on a fixed-dose combination pill of capecitabine and cyclophosphamide administered at flat dose and with metronomic schedule (defined as continuous daily treatment without interruption) in patients with metastatic breast cancer.
- To assess the pharmacokinetics (PKs) and bioavailability of the fixed-dose combination pill of capecitabine and cyclophosphamide administered at different doses/regimens by metronomic schedule in patients with metastatic breast cancer.
Secondary Objectives:
- To assess antitumor activity of the fixed-dose combination pill of capecitabine and cyclophosphamide administered at different doses/regimens by metronomic schedule in patients with metastatic breast cancer given at 3 different doses and schedules (regimen 1=standard dose twice daily [BID], regimen 2=full dose once daily [OD], regimen 3=low dose [OD])
- Disease Control Rate (DCR)
- Overall Response Rate (ORR)
- Time to Progression (TTP) using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria (version 1.1).
- To evaluate the compliance under treatment.
- To describe evolution of toxicities.
- To assess safety all along patient's treatment.
Detailed description
Primary objective will be evaluated at 12 weeks. Patients who show evidence of efficacy will be treated and followed-up until progression of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SAR439281(Cohort 1) | Experimental | Drug: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281Regimen 1: one full-dose tablet containing capecitabine and cyclophosphamide, given BID without interruption |
| SAR439281(Cohort 2) | Experimental | Drug: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281Regimen 2: two tablets containing capecitabine and cyclophosphamide, given OD without interruption |
| SAR439281(Cohort 3) | Experimental | Drug: Fixed-dose combination of capecitabine and cyclophosphamide SAR439281Regimen 3: one tablet containing capecitabine and cyclophosphamide, given OD without interruption |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female ≥18 and ≤65 years old.
- Patients with histologically or cytologically confirmed Metastatic Breast Cancer (HER2 negative, ER/PR positive or negative), who are candidates to receive capecitabine and cyclophosphamide as per Investigator's judgment, and meet either one of the following characteristics:
- Recurrence of the disease following at least 2 lines of chemotherapy failure for metastatic triple negative breast cancer.
- In ER/PR positive breast cancer, recurrence of the disease following at least 1 line of chemotherapy failure and 2 lines of hormonal therapy failure.
- Patients who have been previously treated with capecitabine can be recruited in the study provided:
Key exclusion criteria (36 listed)
- Patients who are HER 2 positive.
- Patients with 3 or more lines of chemotherapy failure for metastatic triple negative breast cancer.
- In ER/PR positive breast cancer, recurrence of the disease following 2 or more lines of chemotherapy failure and/or 3 or more lines of hormonal therapy failure.
- Patients presenting with de novo stage IV metastatic breast cancer, not previously treated for their disease.
- Patients who have already received any metronomic chemotherapy regimen.
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 |
|---|---|---|
| Fixed-dose combination of capecitabine and cyclophosphamide SAR439281Pharmaceutical form:Tablet Route of administration: Oral | Drug | SAR439281(Cohort 1), SAR439281(Cohort 2), SAR439281(Cohort 3) |
Primary outcome
Proportion of patients with adverse events
Time frame: 12 weeks
Assessment of PK parameter: maximum concentration (Cmax)
Time frame: Daily 12 weeks
Assessment of PK parameter: time to reach Cmax (Tmax)
Time frame: Daily 12 weeks
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: 12 weeks
Objective Response Rate (ORR)
Time frame: 12 weeks
Time to Progression (TTP)
Time frame: 12 weeks
Proportion of patients compliant with treatment
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
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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.
Clinical Sciences & Operations study director
Sanofi
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 in people with Breast Cancer Metastatic, run by Sanofi at 5 sites in India.
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 14 inclusion and 36 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: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with adverse events (time frame: 12 weeks). The study lists 3 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 2018.