Breast NeoplasmsPhase 2NCT02229149
Phase 2 Study of Standard Chemotherapy With Trastuzumab, Plus or Minus Pertuzumab, for Pre-treated Metastatic Breast Cancer
A Phase 2 study testing Trastuzumab, Pertuzumab and Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine in people with Breast Neoplasms and Malignant Tumor of the Breast, run by US Oncology Research at 1 site in United States.
Trial summary
This randomized phase 2 study will seek to determine the effectiveness of chemotherapy (physician's choice of vinorelbine, taxane [paclitaxel, docetaxel or nab paclitaxel] or capecitabine) plus trastuzumab vs chemotherapy (physician's choice) plus trastuzumab plus pertuzumab in women with HER2-overexpressing… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Malignant Tumor of the Breast
- What is being tested?
- Trastuzumab, Pertuzumab and Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jan 2022
- 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
- Female, Age ≥ 18 years
- Histologic or cytologic confirmation of human epidermal growth factor receptor 2 (HER2)-positive breast cancer according to most recent biopsy (local testing permitted)
- Measurable or evaluable metastatic disease by Response Evaluation Criteria in Solid Tumors (RECIST) (v1.1)
- Previous treatment with ado-trastuzumab emtansine (T-DM1) for metastatic disease
- Prior therapy with pertuzumab is allowed but not required
- At least 1 but no more than 3 prior chemotherapy regimens for metastatic breast cancer (MBC)
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- Life expectancy > 6 months
- Eastern Cooperative Group (ECOG) performance status ≤ 2
- Left Ventricular Ejection Fraction (LVEF) ≥ 50% at baseline as determined by either echocardiogram (ECHO) or Multi Gated Acquisition Scan (MUGA) and within normal limits per institutional guidelines
- Adequate bone marrow function as indicated by the following:
- Absolute Neutrophil Count (ANC) ≥1500/uL (or 1500 per microliter)
- Platelets ≥100,000/uL
- Hemoglobin >9 g/dL
- Adequate renal function, as indicated by creatinine <1.5 times upper limit of normal (ULN)
- Adequate liver function, as indicated by bilirubin <1.5 times ULN
- Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) <2 x ULN unless liver metastases are present in which case AST and ALT up to 5.x ULN are allowed
- Negative serum pregnancy test within 72 hours before starting study medications for women of childbearing potential
- Women of childbearing potential must be willing to use an acceptable form of birth control (ie, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study Note: Women are considered postmenopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms), or if they have undergone surgical sterilization.
- Signed informed consent obtained prior to any screening procedures.
Who cannot join
- Patients will be excluded from the study based on the following criteria:
- Prior treatment in the metastatic setting with the agent chosen as physician's choice of chemotherapy
- Active infection
- Uncontrolled central nervous system metastases, defined as clinical or radiologic evidence of progression of brain metastases or clinical signs of leptomeningeal disease
- Patients with treated brain metastases are eligible provided they do not have clinical or radiologic evidence of disease progression and have been off of dexamethasone for at least 3 weeks
- Patient is pregnant or lactating
Show all 18Show fewer
- Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin)
- Prior radiation therapy within the last 2 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation).
- Requirement for chronic steroid therapy with a requirement for > 5mg/day of prednisone or the equivalent.
- Treatment with physiologic doses of hydrocortisone up to 20 mg daily (QD) is allowed.
- Requirement for immunosuppressive therapy, such as those used to treat autoimmune disease.
- Concomitant malignancies or previous malignancies within the last 3 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
- History of significant cardiac disease, cardiac risk factors or uncontrolled arrhythmias
- Ejection fraction <50% or below the lower limit of the institutional normal range, whichever is lower
- Known hypersensitivity to trastuzumab or pertuzumab
- Serious medical or psychiatric limitations likely to interfere with participation in this study.
- Symptomatic intrinsic lung disease or extensive tumor involvement of the lungs, resulting in dyspnea at rest or requiring supplemental oxygen
- Patient is currently part of or has participated in any clinical trial of an investigational agent within 1 month prior to enrollment in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Phase II Trial of Chemotherapy of Physician's Choice Plus Trastuzumab Versus Chemotherapy of Physician's Choice Plus Trastuzumab Plus Pertuzumab In Women With Pretreated, HER2-Overexpressing Metastatic Breast Cancer (MBC)
This randomized phase 2 study will seek to determine the effectiveness of chemotherapy (physician's choice of vinorelbine, taxane [paclitaxel, docetaxel or nab paclitaxel] or capecitabine) plus trastuzumab vs chemotherapy (physician's choice) plus trastuzumab plus pertuzumab in women with HER2-overexpressing metastatic breast (MBC) that has been previously treated with ado-trastuzumab emtansine (T-DM1) in the metastatic setting.
Read the detailed description
The current preferred first-line therapy for patients with HER2-overexpressing metastatic breast cancer (MBC) is a taxane plus trastuzumab plus pertuzumab, based on results from the CLEOPATRA trial. For patients with disease that has progressed on trastuzumab and a taxane, ado-trastuzumab emtansine (T-DM1) was recently approved based on results from the EMILIA trial showing superiority in this setting compared with capecitabine plus lapatinib. However, the standard for first-line therapy may change again in the near future, when results become available from the MARIANNE trial, which is evaluating T-DM1 alone or in combination with pertuzumab as upfront therapy. Two important questions that may be raised by the findings of this study are whether pertuzumab is effective as second- or later-line therapy following single-agent T-DM1, and whether pertuzumab administered beyond progression on prior pertuzumab therapy is of clinical benefit as trastuzumab has been proven to be.
The study will seek to determine the efficacy of chemotherapy (physician's choice of vinorelbine, taxane [paclitaxel, docetaxel or nab paclitaxel] or capecitabine) plus trastuzumab vs chemotherapy (physician's choice) plus trastuzumab plus pertuzumab in women with HER2-overexpressing MBC that has been previously treated with T-DM1 in the metastatic setting.
We hypothesize that the addition of pertuzumab to trastuzumab plus chemotherapy will improve median progression-free survival (PFS), compared to trastuzumab plus chemotherapy alone, as second- or later-line therapy in patients who have received prior T-DM1. Patients will be stratified according to whether they have received prior pertuzumab versus not. We will also explore whether continuing treatment with pertuzumab in patients who have been previously treated with pertuzumab improves PFS.
- Conditions
- Breast Neoplasms, Malignant Tumor of the Breast
- Being tested
- Trastuzumab, Pertuzumab, Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine
- Keywords
- breast cancer, metastatic breast cancer, HER2+ 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.
TrastuzumabDrug
Also called Herclon, Herceptin
Treatment for all patients will consist of trastuzumab, given as a loading dose of 8 mg/kg IV on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter.
Patients randomized to the chemotherapy plus trastuzumab arm (without pertuzumab) can receive trastuzumab 6 mg/kg IV every 3 weeks if they are receiving docetaxel or capecitabine on a 3-week cycle, or 4 mg/kg IV every 2 weeks if they are receiving vinorelbine, paclitaxel, or nab-paclitaxel on a 4-week cycle. The loading dose for all patients remains 8 mg/kg.
For patients randomized to the chemotherapy plus trastuzumab plus pertuzumab arm, both trastuzumab and pertuzumab need to be administered every 3 weeks regardless of which chemotherapy agent they are receiving.
PertuzumabDrug
Also called 2C4, Perjeta, Omnitarg
pertuzumab given as a loading dose of 840 mg IV on Day 1 followed by 420 mg IV every 3 weeks.
Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, CapecitabineDrug
Also called Navelbine, Abraxane, Taxol, Taxotere
physician's choice of chemotherapy:
- Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR
- Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR
- Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR
- Docetaxel 75 mg/m2 IV every 3 weeks; OR
- Capecitabine 1500 mg by mouth twice a day (PO BID) 14 days on and then 7 days off.
| Study group | Role | What they receive |
|---|---|---|
| Triple Therapy | Experimental | Physician's choice of chemotherapy plus trastuzumab plus pertuzumab
* trastuzumab, given as a loading dose of 8 mg/kg intravenously (IV, or through the vein) on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter, AND
* physician's choice of chemotherapy:
1. Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR
2. Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR
3. Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR
4. Docetaxel 75 mg/m2 IV every 3 weeks; OR
5. Capecitabine 1500 mg by mouth twice a day (PO BID) 14 days on and then 7 days off.
* AND pertuzumab given as a loading dose of 840 mg IV on Day 1 followed by 420 mg IV every 3 weeks. Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine |
| Double Therapy | Active comparator | Physician's choice of chemotherapy plus trastuzumab
* trastuzumab, given as a loading dose of 8 mg/kg intravenously (IV, or through the vein) on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter, AND
* physician's choice of chemotherapy:
1. Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR
2. Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR
3. Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR
4. Docetaxel 75 mg/m2 IV every 3 weeks; OR
5. Capecitabine 1500 mg PO BID 14 days on and then 7 days off. Receives: Drug: Trastuzumab; Drug: Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
The primary objective of this study is to compare progression-free survival (PFS [also known as time to disease progression]) with the addition of pertuzumab to trastuzumab plus physician's choice of chemotherapy versus trastuzumab plus physician's choice of chemotherapy in patients who have previously received treatment with ado-trastuzumab emtansine (TDM1) for HER2+ metastatic breast cancer.
Measured: 2 years
Secondary outcomes (5)
Progression-free survival (PFS) in patients (pts) with prior pertuzumab
To assess PFS with the addition of pertuzumab to trastuzumab plus physician's choice of chemotherapy in patients who have received prior pertuzumab;
Measured: 2 years
Progression-free survival (PFS) in pts with prior chemotherapy
To compare median PFS with the addition of pertuzumab to trastuzumab plus physician's choice of chemotherapy in patients who have received 1 vs 2-3 prior chemotherapy regimens for metastatic disease;
Measured: 2 years
Number of patients with complete and partial responses
To compare the objective response rates (ORR; complete response [CR] plus partial response [PR]) between the two treatment arms;
Measured: 2 years
Overall survival
To assess overall survival (OS) in each of the treatment arms;
Measured: 2 years
Number of adverse events and serious adverse events
To assess the safety of pertuzumab in combination with trastuzumab and physician's choice of chemotherapy (vinorelbine, paclitaxel, nab-paclitaxel, docetaxel, or capecitabine).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionJan 2022
- Study completionJan 2022
Why it stopped: per Sponsor request
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Oncology Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Neelima Denduluri, MD, Principal investigator, US Oncology Research, McKesson Specialty Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229149
- Sponsor's protocol ID
- 13011
- Other IDs
- ML29212
- Status last verified
- Nov 2022
- First submitted
- 27 Aug 2014
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Chemotherapy of Physician's Choice Plus Trastuzumab Versus Chemotherapy of Physician's Choice Plus Trastuzumab Plus Pertuzumab In Women With Pretreated, HER2-Overexpressing Metastatic Breast Cancer (MBC)
- ClinicalTrials.gov ID
- NCT02229149
- Acronym / sponsor ID
- 13011
- Conditions
- Breast Neoplasms, Malignant Tumor of the Breast
- Keywords
- breast cancer, metastatic breast cancer, HER2+ breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: per Sponsor request
- Enrolment
- 33 participants (actual)
- Lead sponsor
- US Oncology ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Genentech, Inc.
- Study start
- Dec 2014 (actual)
- Primary completion
- Jan 2022 (actual)
- Study completion
- Jan 2022 (actual)
- First posted
- 29 Aug 2014 (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.
This randomized phase 2 study will seek to determine the effectiveness of chemotherapy (physician's choice of vinorelbine, taxane [paclitaxel, docetaxel or nab paclitaxel] or capecitabine) plus trastuzumab vs chemotherapy (physician's choice) plus trastuzumab plus pertuzumab in women with HER2-overexpressing metastatic breast (MBC) that has been previously treated with ado-trastuzumab emtansine (T-DM1) in the metastatic setting.
Detailed description
The current preferred first-line therapy for patients with HER2-overexpressing metastatic breast cancer (MBC) is a taxane plus trastuzumab plus pertuzumab, based on results from the CLEOPATRA trial. For patients with disease that has progressed on trastuzumab and a taxane, ado-trastuzumab emtansine (T-DM1) was recently approved based on results from the EMILIA trial showing superiority in this setting compared with capecitabine plus lapatinib. However, the standard for first-line therapy may change again in the near future, when results become available from the MARIANNE trial, which is evaluating T-DM1 alone or in combination with pertuzumab as upfront therapy. Two important questions that may be raised by the findings of this study are whether pertuzumab is effective as second- or later-line therapy following single-agent T-DM1, and whether pertuzumab administered beyond progression on prior pertuzumab therapy is of clinical benefit as trastuzumab has been proven to be.
The study will seek to determine the efficacy of chemotherapy (physician's choice of vinorelbine, taxane [paclitaxel, docetaxel or nab paclitaxel] or capecitabine) plus trastuzumab vs chemotherapy (physician's choice) plus trastuzumab plus pertuzumab in women with HER2-overexpressing MBC that has been previously treated with T-DM1 in the metastatic setting.
We hypothesize that the addition of pertuzumab to trastuzumab plus chemotherapy will improve median progression-free survival (PFS), compared to trastuzumab plus chemotherapy alone, as second- or later-line therapy in patients who have received prior T-DM1. Patients will be stratified according to whether they have received prior pertuzumab versus not. We will also explore whether continuing treatment with pertuzumab in patients who have been previously treated with pertuzumab improves PFS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple Therapy | Experimental | Drug: Trastuzumab, Drug: Pertuzumab, Drug: Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, CapecitabinePhysician's choice of chemotherapy plus trastuzumab plus pertuzumab * trastuzumab, given as a loading dose of 8 mg/kg intravenously (IV, or through the vein) on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter, AND * physician's choice of chemotherapy: 1. Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR 2. Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR 3. Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR 4. Docetaxel 75 mg/m2 IV every 3 weeks; OR 5. Capecitabine 1500 mg by mouth twice a day (PO BID) 14 days on and then 7 days off. * AND pertuzumab given as a loading dose of 840 mg IV on Day 1 followed by 420 mg IV every 3 weeks. |
| Double Therapy | Active comparator | Drug: Trastuzumab, Drug: Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, CapecitabinePhysician's choice of chemotherapy plus trastuzumab * trastuzumab, given as a loading dose of 8 mg/kg intravenously (IV, or through the vein) on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter, AND * physician's choice of chemotherapy: 1. Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR 2. Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR 3. Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR 4. Docetaxel 75 mg/m2 IV every 3 weeks; OR 5. Capecitabine 1500 mg PO BID 14 days on and then 7 days off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Female, Age ≥ 18 years
- Histologic or cytologic confirmation of human epidermal growth factor receptor 2 (HER2)-positive breast cancer according to most recent biopsy (local testing permitted)
- Measurable or evaluable metastatic disease by Response Evaluation Criteria in Solid Tumors (RECIST) (v1.1)
- Previous treatment with ado-trastuzumab emtansine (T-DM1) for metastatic disease
- At least 1 but no more than 3 prior chemotherapy regimens for metastatic breast cancer (MBC)
Key exclusion criteria (18 listed)
- Prior treatment in the metastatic setting with the agent chosen as physician's choice of chemotherapy
- Active infection
- Uncontrolled central nervous system metastases, defined as clinical or radiologic evidence of progression of brain metastases or clinical signs of leptomeningeal disease
- Patient is pregnant or lactating
- Prior chemotherapy within the last 3 weeks (last 6 weeks for nitrosureas/mitomycin)
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 |
|---|---|---|
| TrastuzumabAlso: Herclon, HerceptinTreatment for all patients will consist of trastuzumab, given as a loading dose of 8 mg/kg IV on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter. Patients randomized to the chemotherapy plus trastuzumab arm (without pertuzumab) can receive trastuzumab 6 mg/kg IV every 3 weeks if they are receiving docetaxel or capecitabine on a 3-week cycle, or 4 mg/kg IV every 2 weeks if they are receiving vinorelbine, paclitaxel, or nab-paclitaxel on a 4-week cycle. The loading dose for all patients remains 8 mg/kg. For patients randomized to the chemotherapy plus trastuzumab plus pertuzumab arm, both trastuzumab and pertuzumab need to be administered every 3 weeks regardless of which chemotherapy agent they are receiving. | Drug | Double Therapy, Triple Therapy |
| PertuzumabAlso: 2C4, Perjeta, Omnitargpertuzumab given as a loading dose of 840 mg IV on Day 1 followed by 420 mg IV every 3 weeks. | Drug | Triple Therapy |
| Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, CapecitabineAlso: Navelbine, Abraxane, Taxol, Taxoterephysician's choice of chemotherapy: * Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR * Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR * Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR * Docetaxel 75 mg/m2 IV every 3 weeks; OR * Capecitabine 1500 mg by mouth twice a day (PO BID) 14 days on and then 7 days off. | Drug | Double Therapy, Triple Therapy |
Primary outcome
Progression-free survival (PFS)
Time frame: 2 years
The primary objective of this study is to compare progression-free survival (PFS [also known as time to disease progression]) with the addition of pertuzumab to trastuzumab plus physician's choice of chemotherapy versus trastuzumab plus physician's choice of chemotherapy in patients who have previously received treatment with ado-trastuzumab emtansine (TDM1) for HER2+ metastatic breast cancer.
5 secondary outcomes
Progression-free survival (PFS) in patients (pts) with prior pertuzumab
Time frame: 2 years
Progression-free survival (PFS) in pts with prior chemotherapy
Time frame: 2 years
Number of patients with complete and partial responses
Time frame: 2 years
Overall survival
Time frame: 2 years
Number of adverse events and serious adverse events
Time frame: 2 years
Results and safety
The study was stopped early (reason given: per Sponsor request). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
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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.
Neelima Denduluri, MD principal investigator
US Oncology Research, McKesson Specialty Health
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 Trastuzumab, Pertuzumab and Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine in people with Breast Neoplasms and Malignant Tumor of the Breast, run by US Oncology Research 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 19 inclusion and 18 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 2 Dec 2022. 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 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: per Sponsor request). 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?
Progression-free survival (PFS) (time frame: 2 years). 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 2 Dec 2022.