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Breast CancerPhase 2TNMNCT02144194

Maintenance Oral Vinorelbine or Observation After Vinorelbine-Docetaxel First Line Chemotherapy in Advanced Breast Ca

A Phase 2 study testing Vinorelbine-Docetaxel and Vinorelbine in people with Breast Cancer, run by Cancer Research Group - Collaborative Group, Beirut, Lebanon. at 2 sites in Lebanon.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel combination given as an initial upfront treatment (first line) to all metastatic breast cancer patients enrolled. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Vinorelbine-Docetaxel and Vinorelbine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
2 sitesLebanon
Study dates
Mar 2012to Dec 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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent
  • Patients >=18 years of age
  • Histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent
  • Measurable and/or non-measurable disease
  • The patient's primary and/or metastatic tumor is HER2 neu negative
  • Documented metastatic disease previously untreated with palliative chemotherapy
  • Adjuvant or neo-adjuvant chemotherapy (including treatment with docetaxel or any other chemotherapy) is allowed with a disease free survival of at least 6 months
  • No symptom or sign of brain metastasis

Who cannot join

  • Operable local recurrence
  • Ascites or pericardial effusion as only site of metastasis
  • Symptomatic peripheral neuropathy > grade 1 according to the NCI Common Toxicity Criteria
  • Radiotherapy to all areas of evaluable disease within the previous 4 weeks
  • Disease significantly affecting absorption
  • Severe hepatic insufficiency
  • Patient previously treated with chemotherapy for their metastatic disease

Trial locations and contacts

2 sites in 1 country.

Lebanon2 sites

  • Hotel Dieu de France University Hospital

    El Achrafiyé, Beirut

  • Hammoud Hospital University Medical Center

    Saida, Saida

Other trials in Lebanon

About this study

Official title: TNM Trial: Upfront Docetaxel [T] and Alternating iv and Oral Vinorelbine [N] Followed, by Either Maintenance Oral Vinorelbine, or Observation for Advanced Breast Cancer

This 2 arms study will assess the efficacy and safety of the Vinorelbine-Docetaxel combination given as an initial upfront treatment (first line) to all metastatic breast cancer patients enrolled. Patients having a disease control following initial treatment, will be randomized to either oral Vinorelbine maintenance arm or Observation arm. The trial will also compare the efficacy and safety of maintenance oral Vinorelbine versus Observation.

Read the detailed description

To our knowledge, this is the first trial evaluating the role of oral Vinorelbine as a maintenance therapy versus observation following a first line treatment with iv/oral Vinorelbine+Docetaxel. Eligible patients will be enrolled in the trial to receive 6 cycles of iv(D1)/oral(D8) Vinorelbine + Docetaxel. For responding and SD patients, after the 6 cycles, they will be randomized either in observation arm or to receive a maintenance chemotherapy with oral Vinorelbine. The oral form of the drug was found to be most appropriate for a long term treatment allowing to preserve QoL of the patients. Oral Vinorelbine will be administered on D1, D8 every 3 weeks during maintenance treatment, until PD, unacceptable toxicity or patient refusal to continue. The trial will assess efficacy/safety of initial Vinorelbine-Docetaxel combination as well as the benefits of maintenance chemotherapy with oral Vinorelbine.

Conditions
Breast Cancer
Being tested
Vinorelbine-Docetaxel, Vinorelbine
Keywords
Oral Vinorelbine, Oral Chemotherapy, Metastatic Breast Cancer, Advanced Breast Cancer, Maintenance treatment
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vinorelbine-DocetaxelDrug

    Also called Navelbine, Navelbine IV, Navelbine Oral, Taxotere

    Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks x 6 cycles

  • VinorelbineDrug

    Also called Navelbine Oral

    Oral Vinorelbine 60mg/m2 or 80mg/m2 D1, D8 every 3 weeks until disease progression, unacceptable toxicities or patient refusal to continue (dose schedule is at investigator's discretion)

Study groups in NCT02144194
Study groupRoleWhat they receive
Maintenance treatmentExperimentalInitial treatment Vinorelbine-Docetaxel Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks for 6 cycles Followed by: Oral Vinorelbine 60mg/m2 D1, D8 or 80mg/m2 D1, D8 (dose schedule at investigator's discretion) Every 3 weeks until disease progression, unacceptable toxicities or patient refusal to continue
Receives: Drug: Vinorelbine-Docetaxel; Drug: Vinorelbine
Observation armExperimentalInitial treatment: Vinorelbine-Docetaxel Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks for 6 cycles Patients in the observation arm will not be administered any treatment after Vinorelbine-Docetaxel
Receives: Drug: Vinorelbine-Docetaxel

What is being measured

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

  1. Time To Disease Progression of patients who are treated with Vinorelbine-Docetaxel followed by maintenance oral Vinorelbine vs patients treated with Vinorelbine-Docetaxel without maintenance treatment

    Measured: Up to 36 months

Secondary outcomes (5)

  1. Overall Response Rate

    Measured: Up to 36 months

  2. Duration of Response

    Measured: Up to 36 months

  3. Quality of Life

    Measured: Up to 36 months

  4. Number and percentage of participants with Adverse Events

    Measured: Participants will be followed for the entired duration of the study, an expected average of 60 months

  5. 3-Y Overall Survival

    Measured: Up to 36 months

Timeline

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

  1. First posted21 May 2014 (estimated)
  2. Study startMar 2012
  3. Primary completionJun 2017 (estimated)
  4. Study completionDec 2017 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02144194
Sponsor's protocol ID
CRG SE036
Acronym
TNM
Status last verified
Feb 2017
First submitted
15 May 2014
Last updated
9 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinorelbine-Docetaxel and Vinorelbine in people with Breast Cancer, run by Cancer Research Group - Collaborative Group, Beirut, Lebanon. at 2 sites in Lebanon.

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 8 inclusion and 7 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 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Lebanon. 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?

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?

Time To Disease Progression of patients who are treated with Vinorelbine-Docetaxel followed by maintenance oral Vinorelbine vs patients treated with Vinorelbine-Docetaxel without maintenance treatment (time frame: Up to 36 months). 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 NCT02144194.

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 9 Feb 2017.

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