Metastatic Breast CancerPhase 2NCT01910870
Phase II Pilot Study Assessing Efficacy of a Cisplatin - Metronomic Cyclophosphamide Treatment in Patients With Metastatic Triple Negative Breast Cancer Resistant to Anthracyclines and Taxanes
A Phase 2 study testing Cisplatin and Metronomic Cyclophosphamide in people with Metastatic Breast Cancer, run by Centre Jean Perrin at 1 site in France.
Trial summary
To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Cisplatin and Metronomic Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Sep 2016
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 ans,
- Performance status < 2,
- Patient with metastatic breast cancer stade IV triple negative histologically confirmed
- Measurable or not disease but radiologically evaluable (RECIST 1.1),
- Negative Hormonal Receptors (Estrogens and/or Progesterone), HER-2 negative (Score 0 or 1 by Immunochemistry (IHC), negative FISH if score IHC 2),
- Patient with a progression during or after an anthracyclines and/or taxanes treatment receiving in neo-adjuvant or adjuvant regimen according to a resistance defined as a documented disease progression in the last 12 month after the last dose of taxanes or anthracyclines,
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- Patient non previously treated by platinum salts,
- Hematological Functions: Neutrophiles ≥ 1,5.109/L, Platelets ≥ 100.109/L, Leucocytes > 3 000/mm3, Hb > 9g/dL,
- Hepatic Functions : total Bilirubin ≤ 1,5 time upper normal value (UNV), ASAT ≤ 2 ,5 time UNV, ALAT ≤ 2,5 time UNV, Alkaline Phosphatase ≤ 2,5 time UNV (< 5 time UNV if case of hepatic metastasis),
- Renal Functions: Creatinine Clearance ≥ 60 mL/min,
- Patient signed the consent study form,
- Patient affiliated to a social security regimen (law of 9 August 2004).
Who cannot join
- Male Patients,
- Unknown hormonal Receptors
- Positive HER-2 (Score 3 in IHC or positive FISH)
- Pregnant or breastfeeding patient, or in age of pregnancy or predicting to be pregnant in the 6 months after the end of treatment,
- Patient not using contraceptive treatment during the treatment or after the 6 months after the end of treatment,
- Patient is a ward,
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- Patient suffering from a non compatible disease with the enrollment in the study,
- Cardiac, renal, medullar, respiratory or hepatic insufficiency, clinically significant cardiovascular disease (including myocardiac infarct, unstable angina, symptomatic congestive heart failure, uncontrolled cardiac arrhythmia) < 1 year before the study enrollment or randomisation,
- Patient with pulmonary lymphangitis or symptomatic pleural effusion (grade≥2), meningeal known carcinoma or symptoms of cerebromeningeal invasion, brain metastases unless treatment and stability for at least 4 weeks (no steroids or anti-convulsive).
- Uncontrolled diabetes,
- Psychiatric or neurological significant abnormality,
- Peripheric Neuropathy > grade 2,
- Antecedent of hypersensibility to one of study treatment or one of used excipients,
- Urinary tract infection or acute hemorrhagic cystitis in progress
- Concomitant treatment with a medicine containing phenytoin or medication received in the context of a trial, or participation in another therapeutic clinical trial within <30 days prior treatment with chemotherapy.
- Geographically unstable patient in the next 6 months or remaining distance to the treatment center making it difficult to follow in the study,
- Known history of abuse of narcotic or other drug or alcohol
- History of surgery within 28 days before the start of treatment,
- Patient unwilling or unable to comply with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Cisplatin, Metronomic Cyclophosphamide
- Keywords
- Early-relapse
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CisplatinDrug
25 mg/m² I.V. (day 1 to day 3) Total dose : 75 mg/m² every 3 weeks
Metronomic CyclophosphamideDrug
Also called Endoxan
150 mg per os from day 1 to day 14 (total dose = 2100 mg) every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cisplatin - Metronomic Cyclophosphamide | Experimental | Cisplatin 25 mg/m² (day 1 to day 3) every 3 weeks Metronomic cyclophosphamide 150 mg (day 1 to day 14) every 3 weeks Receives: Drug: Cisplatin; Drug: Metronomic Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of cisplatin - metronomic cyclophosphamide treatment
Measured: 18 months and 6 weeks
Secondary outcomes (4)
Disease free progression
Measured: 3 years
safety profile of cisplatin - metronomic cyclophosphamide association
Number of Participants with Adverse Events
Measured: 18 months and 6 weeks
Overall survival
Measured: 5 years
Predictive factors to response and/or resistance treatment
Measured: 18 months and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Because of difficulties in recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Ange MOURET-REYNIER, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01910870
- Sponsor's protocol ID
- META1 - CJP4.1
- Status last verified
- Jul 2016
- First submitted
- 28 May 2013
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Study Assessing Efficacy of a Cisplatin - Metronomic Cyclophosphamide Treatment in Patients With Metastatic Triple Negative Breast Cancer Resistant to Anthracyclines and Taxanes
- ClinicalTrials.gov ID
- NCT01910870
- Acronym / sponsor ID
- META1 - CJP4.1
- Conditions
- Metastatic Breast Cancer
- Keywords
- Early-relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Because of difficulties in recruiting
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 30 Jul 2013 (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.
To evaluate response rate of cisplatin - metronomic cyclophosphamide treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cisplatin - Metronomic Cyclophosphamide | Experimental | Drug: Cisplatin, Drug: Metronomic CyclophosphamideCisplatin 25 mg/m² (day 1 to day 3) every 3 weeks Metronomic cyclophosphamide 150 mg (day 1 to day 14) every 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age > 18 ans,
- Performance status < 2,
- Patient with metastatic breast cancer stade IV triple negative histologically confirmed
- Measurable or not disease but radiologically evaluable (RECIST 1.1),
- Negative Hormonal Receptors (Estrogens and/or Progesterone), HER-2 negative (Score 0 or 1 by Immunochemistry (IHC), negative FISH if score IHC 2),
Key exclusion criteria (19 listed)
- Male Patients,
- Unknown hormonal Receptors
- Positive HER-2 (Score 3 in IHC or positive FISH)
- Pregnant or breastfeeding patient, or in age of pregnancy or predicting to be pregnant in the 6 months after the end of treatment,
- Patient not using contraceptive treatment during the treatment or after the 6 months after the end of treatment,
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 |
|---|---|---|
| Cisplatin25 mg/m² I.V. (day 1 to day 3) Total dose : 75 mg/m² every 3 weeks | Drug | Cisplatin - Metronomic Cyclophosphamide |
| Metronomic CyclophosphamideAlso: Endoxan150 mg per os from day 1 to day 14 (total dose = 2100 mg) every 3 weeks | Drug | Cisplatin - Metronomic Cyclophosphamide |
Primary outcome
Response rate of cisplatin - metronomic cyclophosphamide treatment
Time frame: 18 months and 6 weeks
4 secondary outcomes
Disease free progression
Time frame: 3 years
safety profile of cisplatin - metronomic cyclophosphamide association
Time frame: 18 months and 6 weeks
Overall survival
Time frame: 5 years
Predictive factors to response and/or resistance treatment
Time frame: 18 months and 6 weeks
Results and safety
The study was stopped early (reason given: Because of difficulties in recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 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.
Marie-Ange MOURET-REYNIER, MD principal investigator
Centre Jean Perrin
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 Cisplatin and Metronomic Cyclophosphamide in people with Metastatic Breast Cancer, run by Centre Jean Perrin at 1 site in France.
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 12 inclusion and 19 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: stopped early, as of the sponsor's last update on 18 May 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 France. 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 was stopped early (reason given: Because of difficulties in recruiting). Results are not available in the source record.
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?
Response rate of cisplatin - metronomic cyclophosphamide treatment (time frame: 18 months and 6 weeks). 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 18 May 2018.