Breast CancerPhase 1/2NCT02658084
Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer
A Phase 1/2 study testing Vinorelbine and Trastuzumab Emtansine in people with Breast Cancer and Metastatic Breast Cancer, run by University of Miami at 1 site in United States.
Trial summary
The study proposes to evaluate the safety and efficacy of the combination of trastuzumab emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Vinorelbine and Trastuzumab Emtansine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Apr 2017to 11 Oct 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologically or cytologically documented breast cancer.
- Metastatic or unresectable locally advanced/recurrent breast cancer.
- HER2-positive disease documented as: Immunohistochemistry (IHC) 3+ positive, and/or Fluorescence in situ hybridization (FISH) ≥ 2.0, and/or gene copy number greater than 6, on previously collected tumor or metastatic site. IHC testing, FISH assay(s), and gene copy number may all have been performed; however, a positive result from only one of the above is required for eligibility.
- Documented disease progression on the last regimen by radiographic measurement (progression demonstrated by tumor markers only is unacceptable).
- Documented disease progression (by investigator assessment) after at least one regimen of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting.
- For patients with hormone receptor-positive disease: disease progression or recurrence in any setting on prior hormonal therapy, given with or without HER2 directed therapy.
Show all 27Show fewer
- Measurable or bone only disease.
- Prior treatment with a taxane, in the neoadjuvant, adjuvant, locally advanced or metastatic setting.
- A minimum of 6 weeks of prior trastuzumab for the treatment of metastatic or unresectable locally advanced/recurrent disease is required.
- Prior use of Pertuzumab in any setting is permitted (but not required).
- Prior use of Lapatinib in any setting is permitted (but not required).
- Age ≥ 18 years
- Life expectancy ≥ 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. See Appendix C for details.
- Patients must have normal organ and marrow function as defined below:
- absolute neutrophil count (ANC) >1,500 cells/mm3
- platelets >100,000 cells/mm3
- hemoglobin > 9.0 g/dL (Patients are permitted to receive transfused red blood cells to achieve this level.)
- total bilirubin ≤1.5 X institutional upper limit of normal (ULN) [Note: For patients with previously documented Gilbert's syndrome, total bilirubin ≤ 3 mg/dL.]
- Aspartate aminotransferase (AST/SGOT) ≤ 2.5 X ULN
- Alanine aminotransferase (ALT/SGPT) ≤ 2.5 X ULN
- alkaline phosphatase (alk phos) ≤ 2.5 X ULN
- serum creatinine < 1.5 X ULN
- International normalized ratio (INR) < 1.5 X ULN
- Left ventricular ejection fraction (LVEF) ≥ 50% by either echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA).
- Negative results of serum pregnancy test for premenopausal women of reproductive capacity and for women < 12 months after menopause. For men and women of childbearing potential, agreement by the patient and/or partner to use two effective non-hormonal forms of barrier contraception at the same time, throughout treatment on study. Women should agree to continued use for at least 90 days after the end of treatment. Men should agree to continued use for at least 7 months after the end of treatment. Examples of non-hormonal barrier contraception include: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide.
- Ability to understand and willingness to sign a written informed consent and HIPAA document.
Who cannot join
- Chemotherapy ≤21 days prior to first dose of study treatment
- If last dose of trastuzumab was:
- 6mg/kg then ≤21 days prior to first dose of study treatment
- 4mg/kg then ≤14 days prior to first dose of study treatment
- 2mg/kg then ≤7 days prior to first dose of study treatment
- Lapatinib ≤14 days prior to first dose of study treatment
Show all 37Show fewer
- Pertuzumab ≤21 days prior to first dose of study treatment
- Hormone therapy ≤7 days prior to first dose of study treatment
- Investigational therapy or any other such experimental therapy ≤28 days prior to first dose of study treatment
- Prior treatment with trastuzumab emtansine, (on or off a study protocol)
- Prior use of vinorelbine (in any setting).
- Previous radiotherapy for the treatment of unresectable, locally advanced, recurrent or metastatic breast cancer is not allowed if:
- The last fraction of radiotherapy has been administered within 14 days prior to study enrollment
- More than 25% of marrow-bearing bone has been irradiated
- Brain metastases that are untreated or symptomatic, or require any radiation, surgery, or continued steroid therapy to control symptoms from brain metastases within 14 days of study enrollment.
- History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins.
- History of exposure to the following cumulative doses of anthracyclines:
- Doxorubicin ≥550mg/m2
- Liposomal doxorubicin >500 mg/m2
- Epirubicin >900 mg/m2
- Mitoxantrone > 120 mg/m2
- If another anthracycline, or more than one anthracycline, has been used, the cumulative dose must not exceed the equivalent of ≥550 mg/m2 doxorubicin.
- Current peripheral neuropathy of Grade ≥3 per the NCI CTCAE, v4.0
- The patient has not recovered from any other acute toxicity (to Grade ≤1 as per NCI CTCAE v4.03) prior to study enrollment.
- History of other malignancy within the last 3 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome.
- Cardiopulmonary Function Criteria:
- Current unstable ventricular arrhythmia requiring treatment
- History of symptomatic congestive heart failure (CHF) as per New York Heart Association (NYHA) Classes II-IV; see Appendix D for details.
- History of myocardial infarction or unstable angina within 6 months of study enrollment
- History of a decrease in LVEF to < 40% or symptomatic CHF with previous trastuzumab treatment
- Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy
- Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease)
- Major surgical procedure or significant traumatic injury within 28 days -before enrollment or anticipation of the need for major surgery during the course of study treatment
- Current pregnancy or lactation
- Current known uncontrolled active infection with HIV, hepatitis B, and/or hepatitis C virus
- Any uncontrolled, intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
- Any other serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Study to Evaluate the Safety and Efficacy of Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer
The study proposes to evaluate the safety and efficacy of the combination of trastuzumab emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.
Read the detailed description
This is a Phase I/II, single arm, open-label clinical trial designed to establish the recommended phase II dose (RP2D) of vinorelbine with a fixed dose of trastuzumab emtansine. The study will also evaluate the safety and efficacy of the RP2D in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic, locally advanced, or unresectable breast cancer. The study will be opened to accrual at the University of Miami Sylvester Comprehensive Cancer Center (SCCC) main campus and constituent satellite sites, Deerfield Beach and Plantation.
This phase I/II study will have a total of 50 enrolled patients, taking into account 10% drop-out in the phase II follow-up. The duration anticipated to enroll all study subjects in Phase I/II is 2 years. The estimated duration for the Investigators to complete this study (Phase I/II) is 4.5 to 5 years.
For the phase I portion, standard 3+3 dose escalation/de-escalation design will be applied. Approximately 15 to 21 patients will be needed to establish the recommended phase II dose (RP2D). For the phase II portion of the study, up to 35 patients will be treated at the RP2D (MTD) including 6 patients treated at RP2D in phase I. Patients may remain on treatment with the combination until disease progression or unmanageable toxicity.
Tumor assessments will be conducted every 6 weeks (±7 days) to week 18. Thereafter, these assessments will be done every 12 weeks (±7 days). These will shall occur regardless of dose delays or dose interruptions, until Investigator-assessed progressive disease (PD), or death, whichever occurs first. More frequent tumor assessments may be performed as clinically indicated, at the discretion of the treating Investigator.
For the phase II portion of the study - patients who discontinue treatment for reasons other than PD will continue to have required tumor assessments completed until PD or the initiation of a new therapy. Once patients have progressed, they will be followed for survival approximately every 3 months for at least 3 years. Subsequent anti-cancer therapies will be documented until study completion.
Patients who are discontinued from study treatment will return for the Study Treatment Discontinuation Visit approximately 30 days (±7 days) after the last dose of study treatment.
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Being tested
- Vinorelbine, Trastuzumab Emtansine
- Keywords
- HER2-Positive, Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VinorelbineDrug
Also called Vinorelbine tartrate, Navelbine
Administered as an intravenous infusion on Day 1 and Day 8 of every 21-day cycle.
Trastuzumab EmtansineDrug
Also called Kadcyla, T-DM1, Trastuzumab-MCC-DM1
Administered as an intravenous infusion on Day 1 of every 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: T-DM1 + Vinorelbine | Experimental | One cycle of Trastuzumab Emtansine (T-DM1)/Vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). The recommended (starting) dose of trastuzumab emtansine is 3.6 mg/kg given as an intravenous infusion on Day 1 of every 21-day cycle. The starting dose of Vinorelbine is 22.5 mg/m2 given as a direct intravenous push over 6-10 minutes on day 1 and day 8 of every 3-week (i.e. 21-day) cycle. Participants will be treated until documented disease progression or other criteria for discontinuation. Approximately 15 to 21 patients will be needed to establish the recommended phase II dose (RP2D). Receives: Drug: Vinorelbine; Drug: Trastuzumab Emtansine |
| Phase 2: T-DM1 + RP2D Vinorelbine | Experimental | One cycle of trastuzumab emtansine (T-DM1)/vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). Participants will receive the recommended Phase 2 Dose (RPSD) of Vinorelbine with the fixed dose (3.6 mg/kg) of Trastuzumab Emtansine. Participants will be treated until documented disease progression or other criteria for discontinuation. Up to 35 patients will be treated at the RP2D (MTD) including 6 patients treated at RP2D in phase I. Receives: Drug: Vinorelbine; Drug: Trastuzumab Emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 - Maximum Tolerated Dose (MTD) of Vinorelbine in Combination With a Fixed Dose of Trastuzumab Emtansine.
Identifying the Maximum Tolerated Dose (MTD) of Vinorelbine combined with a fixed dose of Trastuzumab Emtansine to be recommended for the phase II portion of the study (RP2D).
Measured: 2 years
Phase 2 - Rate of Progression-Free Survival (PFS)
Rate of Progression-Free Survival (PFS) in participants receiving the RP2D of vinorelbine in combination with Trastuzumab Emtansine therapy. PFS is defined as the time from date from first treatment received on study until documented disease progression or death (by any cause, in the absence of progression). In progression-free patients, PFS will be censored at the last evaluable tumor assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Measured: Up to 5 years
Phase 1 - Rate of Participants Experiencing Adverse Events
Rate of participants experiencing adverse events including dose-limiting toxicities (DLTs) and serious adverse events (SAEs).
Measured: 18 months
Secondary outcomes (3)
Phase 2 - Clinical Benefit Rate (CBR)
Rate of participants achieving best overall response of complete response (CR), partial response (PR) or stable disease (SD) for >/= 6 months on protocol therapy, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Measured: Up to 5 years
Phase 2 - Overall Survival (OS) Rate
Overall Survival (OS) is defined as the elapsed time from date from first treatment received on study to death or date of censoring. Patients alive or those lost to follow-up will be censored at the last date of contact (or last date known to be alive).
Measured: Up to 5 Years
Phase 2 - Objective Response Rate (ORR)
Rate of participants achieving a best overall response of complete response (CR) or partial response (PR) to protocol therapy according to Response Evaluation Criteria in Solid Tumors (RECIST) v. 1.1 criteria.
Measured: 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 posted18 Jan 2016 (estimated)
- Study start12 Apr 2017
- Primary completion11 Oct 2018
- Study completion11 Oct 2018
Why it stopped: Terminated due to low accrual and toxicity concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Reshma Mahtani, University of Miami
- Investigators
- Reshma Mahtani, DO, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658084
- Sponsor's protocol ID
- 20151055
- Status last verified
- Apr 2019
- First submitted
- 14 Jan 2016
- Last updated
- 17 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety and Efficacy of Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT02658084
- Acronym / sponsor ID
- 20151055
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Keywords
- HER2-Positive, Metastatic Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low accrual and toxicity concerns.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 11 Oct 2018 (actual)
- Study completion
- 11 Oct 2018 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Posted 17 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study proposes to evaluate the safety and efficacy of the combination of trastuzumab emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.
Detailed description
This is a Phase I/II, single arm, open-label clinical trial designed to establish the recommended phase II dose (RP2D) of vinorelbine with a fixed dose of trastuzumab emtansine. The study will also evaluate the safety and efficacy of the RP2D in patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic, locally advanced, or unresectable breast cancer. The study will be opened to accrual at the University of Miami Sylvester Comprehensive Cancer Center (SCCC) main campus and constituent satellite sites, Deerfield Beach and Plantation.
This phase I/II study will have a total of 50 enrolled patients, taking into account 10% drop-out in the phase II follow-up. The duration anticipated to enroll all study subjects in Phase I/II is 2 years. The estimated duration for the Investigators to complete this study (Phase I/II) is 4.5 to 5 years.
For the phase I portion, standard 3+3 dose escalation/de-escalation design will be applied. Approximately 15 to 21 patients will be needed to establish the recommended phase II dose (RP2D). For the phase II portion of the study, up to 35 patients will be treated at the RP2D (MTD) including 6 patients treated at RP2D in phase I. Patients may remain on treatment with the combination until disease progression or unmanageable toxicity.
Tumor assessments will be conducted every 6 weeks (±7 days) to week 18. Thereafter, these assessments will be done every 12 weeks (±7 days). These will shall occur regardless of dose delays or dose interruptions, until Investigator-assessed progressive disease (PD), or death, whichever occurs first. More frequent tumor assessments may be performed as clinically indicated, at the discretion of the treating Investigator.
For the phase II portion of the study - patients who discontinue treatment for reasons other than PD will continue to have required tumor assessments completed until PD or the initiation of a new therapy. Once patients have progressed, they will be followed for survival approximately every 3 months for at least 3 years. Subsequent anti-cancer therapies will be documented until study completion.
Patients who are discontinued from study treatment will return for the Study Treatment Discontinuation Visit approximately 30 days (±7 days) after the last dose of study treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1: T-DM1 + Vinorelbine | Experimental | Drug: Vinorelbine, Drug: Trastuzumab EmtansineOne cycle of Trastuzumab Emtansine (T-DM1)/Vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). The recommended (starting) dose of trastuzumab emtansine is 3.6 mg/kg given as an intravenous infusion on Day 1 of every 21-day cycle. The starting dose of Vinorelbine is 22.5 mg/m2 given as a direct intravenous push over 6-10 minutes on day 1 and day 8 of every 3-week (i.e. 21-day) cycle. Participants will be treated until documented disease progression or other criteria for discontinuation. Approximately 15 to 21 patients will be needed to establish the recommended phase II dose (RP2D). |
| Phase 2: T-DM1 + RP2D Vinorelbine | Experimental | Drug: Vinorelbine, Drug: Trastuzumab EmtansineOne cycle of trastuzumab emtansine (T-DM1)/vinorelbine combination treatment is defined as 21-days (i.e. 3 weeks). Participants will receive the recommended Phase 2 Dose (RPSD) of Vinorelbine with the fixed dose (3.6 mg/kg) of Trastuzumab Emtansine. Participants will be treated until documented disease progression or other criteria for discontinuation. Up to 35 patients will be treated at the RP2D (MTD) including 6 patients treated at RP2D in phase I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Histologically or cytologically documented breast cancer.
- Metastatic or unresectable locally advanced/recurrent breast cancer.
- HER2-positive disease documented as: Immunohistochemistry (IHC) 3+ positive, and/or Fluorescence in situ hybridization (FISH) ≥ 2.0, and/or gene copy number greater than 6, on previously collected tumor or metastatic site. IHC testing, FISH assay(s), and gene copy number may all have been performed; however, a positive result from only one of the above is required for eligibility.
- Documented disease progression on the last regimen by radiographic measurement (progression demonstrated by tumor markers only is unacceptable).
- Documented disease progression (by investigator assessment) after at least one regimen of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting.
Key exclusion criteria (37 listed)
- Chemotherapy ≤21 days prior to first dose of study treatment
- If last dose of trastuzumab was:
- Lapatinib ≤14 days prior to first dose of study treatment
- Pertuzumab ≤21 days prior to first dose of study treatment
- Hormone therapy ≤7 days prior to first dose of study 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 |
|---|---|---|
| VinorelbineAlso: Vinorelbine tartrate, NavelbineAdministered as an intravenous infusion on Day 1 and Day 8 of every 21-day cycle. | Drug | Phase 1: T-DM1 + Vinorelbine, Phase 2: T-DM1 + RP2D Vinorelbine |
| Trastuzumab EmtansineAlso: Kadcyla, T-DM1, Trastuzumab-MCC-DM1Administered as an intravenous infusion on Day 1 of every 21-day cycle. | Drug | Phase 1: T-DM1 + Vinorelbine, Phase 2: T-DM1 + RP2D Vinorelbine |
Primary outcome
Phase 1 - Maximum Tolerated Dose (MTD) of Vinorelbine in Combination With a Fixed Dose of Trastuzumab Emtansine.
Time frame: 2 years
Identifying the Maximum Tolerated Dose (MTD) of Vinorelbine combined with a fixed dose of Trastuzumab Emtansine to be recommended for the phase II portion of the study (RP2D).
Phase 2 - Rate of Progression-Free Survival (PFS)
Time frame: Up to 5 years
Rate of Progression-Free Survival (PFS) in participants receiving the RP2D of vinorelbine in combination with Trastuzumab Emtansine therapy. PFS is defined as the time from date from first treatment received on study until documented disease progression or death (by any cause, in the absence of progression). In progression-free patients, PFS will be censored at the last evaluable tumor assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Phase 1 - Rate of Participants Experiencing Adverse Events
Time frame: 18 months
Rate of participants experiencing adverse events including dose-limiting toxicities (DLTs) and serious adverse events (SAEs).
3 secondary outcomes
Phase 2 - Clinical Benefit Rate (CBR)
Time frame: Up to 5 years
Phase 2 - Overall Survival (OS) Rate
Time frame: Up to 5 Years
Phase 2 - Objective Response Rate (ORR)
Time frame: Up to 5 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Reshma Mahtani, DO principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vinorelbine and Trastuzumab Emtansine in people with Breast Cancer and Metastatic Breast Cancer, run by University of Miami at 1 site in United States.
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 27 inclusion and 37 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 17 Apr 2019. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 17 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase 1 - Maximum Tolerated Dose (MTD) of Vinorelbine in Combination With a Fixed Dose of Trastuzumab Emtansine. (time frame: 2 years). 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 17 Apr 2019.