AzTrials
AzTrials

Metastatic Breast CancerPhase 2META2NCT01910844

Phase II Pilot Study Assessing Efficacy of a Cisplatin - Métronomic Cyclophosphamide Treatment in Patients With Stade IV Triple Negative Breast Cancer Secondary Resistant to Anthracyclines and Taxanes

A Phase 2 study testing Cisplatin and Cyclophosphamide in people with Metastatic Breast Cancer, run by Centre Jean Perrin at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and Taxanes. 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 Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 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

  • 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 exposed to anthracyclines and/or taxanes in neo-adjuvant or adjuvant setting,
Show all 16Show fewer
  • Patient with a progression and for whom anthracyclines and/or taxanes treatment cannot be delivered and according to a resistance defined as :
  • In the last 12 months after the last dose of taxanes or anthracyclines in adjuvant or neoadjuvant setting or,
  • During or after a first metastatic chemtotherapy line and where taxanes and anthracyclines cannot be delivered according to :
  • either a secondary resistance after an initial response to chemotherapy but a relapse observed either during the treatment or in the 4 months after the end of chemotherapy.
  • either a sensitivity to treatment defined by a relapse after more than 4 months after the first chemotherapy metastatic line,
  • either intolerance to anthracyclines (doxorubicin 240-400 mg/m² ou equivalent to doxorubicin (epirubicin) 300-550mg/m²)
  • 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: Serum Creatinine ≤ 1,5 time UNV (and if value > 1,5 time UNV, so Clearance ≥ 60 mL/min) or Clearance ≥ 40 mL/min in case of RMI,
  • 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,
Show all 19Show fewer
  • 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.

France1 site

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

Other trials in France

About this study

Study assessing efficacy of a Cisplatine- Métronomic cyclophosphamide treatment in Patients with Metastatic Triple Negative breast Cancer Secondary Resistant to Anthracyclines and Taxanes.

Keywords
triple negative breast cancer, late-relapse
Medical subject headings
Breast Neoplasms, Triple Negative 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. from day 1 to day 3 - total dose = 75 mg/m² every 3 weeks

  • CyclophosphamideDrug

    Also called Endoxan

    Metronomic cyclophosphamide per os 150 mg from day 1 to day 14 - total dose 2100 mg every 3 weeks

Study groups in NCT01910844
Study groupRoleWhat they receive
Cisplatin - Metronomic CyclophosphamideExperimentalCisplatin 25 mg/m² from day 1 to day 3 every 3 weeks Metronomic Cyclophosphamide 150 mg from day 1 to day 14 every 3 weeks
Receives: Drug: Cisplatin; Drug: Cyclophosphamide

What is being measured

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

  1. Response rate of cisplatine - metronomic cyclophosphamide treatment

    Measured: 12 months and 6 weeks

Secondary outcomes (4)

  1. Disease free progression

    Measured: 3 years

  2. Safety profile of cisplatin - metronomic cyclophosphamide association

    Number of Participants with Adverse Events

    Measured: 12 months and 6 weeks

  3. Overall survival

    Measured: 5 years

  4. Predictive factors to response and/or resistance treatment

    Measured: 12 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.

  1. First posted30 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionSep 2016
  4. Study completionSep 2016

Why it stopped: Because of difficulties in recruting

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01910844
Sponsor's protocol ID
CJP 4.2 - META2
Acronym
META2
Status last verified
Jul 2016
First submitted
28 May 2013
Last updated
11 Oct 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin and 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 16 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 11 Oct 2016. 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 recruting). 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 cisplatine - metronomic cyclophosphamide treatment (time frame: 12 months and 6 weeks). 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 NCT01910844.

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 11 Oct 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in