Breast CancerPhase 2NCT03058939
Assessing the Response Rate of Neo-adjuvant Paclitaxel (Taxol) in Nigerian Women With Breast Cancer
A Phase 2 study testing Paclitaxel, Perjeta and Herceptin SC in people with Breast Cancer and Breast Cancer Stage II, run by University of Chicago at 1 site in Nigeria.
Trial summary
This is a two-stage phase II study with a single arm design. It will be conducted in women with breast cancer with stages IIA to IIIC (defined by AJCC 2009 classification) of all histological subtypes. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III
- What is being tested?
- Paclitaxel, Perjeta and Herceptin SC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNigeria
- Study dates
- Nov 2018to Jun 2019
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ages of 18 to 70 years old.
- Biopsy-accessible breast tumor of significant size for core needle biopsy (≥ 2cm).
- Patients with histologically confirmed carcinoma of the female breast with any or unknown HRs/HER2 status
- Clinical stages IIA -IIIC. (AJCC 2009) (Appendix A)
- Chemotherapy-naïve patients (for this malignancy)
- Performance status: ECOG performance status 0-3 (Appendix B)
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- Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive LHRH agonist Zoladex (goserelin) for two years starting from the commencement of the study medications.
- Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:
- Granulocyte ≥ 1,500/μL
- Platelet count ≥ 100,000/μL
- Absolute neutrophil count (ANC) ≥ l500/μL
- Hemoglobin³10g/dL
- Bilirubin ≤ 1.5 x upper limit of normal
- SGOT and SGPT < 2.5 x upper limit of normal for patients without liver metastases
- Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by CKD EPI equation (see http://mdrd.com/ for calculator)
Who cannot join
- Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Patients will agree to continue the use of acceptable form of contraception for 30 days from the date of last drug administration.
- Patients with brain metastasis.
- Serious, uncontrolled, concurrent infection(s).
- Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy. Patient who have received tamoxifen or raloxifene for purposes of chemoprevention (e.g. Breast Cancer Prevention Trial or for other past indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy will be discontinued at least one month before the patient is enrolled on this study.
- Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS).
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- Participation in any investigational drug study within 4 weeks preceding the start of study treatment.
- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled Diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements.
- Unwillingness to participate or inability to comply with the protocol for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the REsponse Rate of Weekly Neo-adjuvanT pacliTAxel (Taxol) in Nigerian Women With Breast Cancer (ARETTA)
This is a two-stage phase II study with a single arm design. It will be conducted in women with breast cancer with stages IIA to IIIC (defined by AJCC 2009 classification) of all histological subtypes. All patients will receive 16 doses of paclitaxel; three breast ultrasound tests and tumor pathologic response evaluation will be used to assess the response to treatment.
Read the detailed description
Each patient will be assigned one of the following groups: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 8) unknown (not assessable, insufficient data). Patients with a good response to 8 doses of paclitaxel (complete response or partial response that are operable) will receive an additional 8 courses of paclitaxel chemotherapy before surgery and radiotherapy. The overall response for these patients will be assessed by ultrasonography after a total of 16 weeks of Taxol therapy. Patients with poor response (defined as stable disease or progressive disease or partial response inoperable) as best response after eight weekly courses of paclitaxel will receive 8 cycles of weekly PC. The overall response for these patients will also be assessed by ultrasonography after 8 courses of PC therapy. Patients with poor response to 8 courses of paclitaxel followed by 8 courses of PC based on ultrasound assessment will be regarded as failing to respond to treatment. These patients will receive 4 cycles of 3-weekly FEC and will be followed up. Patients in response groups 4-8 above will be considered as failing to respond to treatment.
All conclusions will be based on all eligible patients. The schema for the study is presented in Figures 4-1, 4-2 and 4-3. Patients with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time will be classified as having "symptomatic deterioration". Every effort will be made to document the objective progression even after discontinuation of treatment. All Premenopausal patients will receive LHRH agonist for two years for contraception and fertility preservation. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors ER and PgR (see glossary and section 10.3) and according to the state of primary menopause (see glossary) at the onset of the study. Patients with HER2-positive disease (see glossary and section 10.3) will receive 5 threeweekly courses of trastuzumab (Herceptin SC) with pertuzumab (Perjeta). After that pts will continue receiving trastuzumab to complete total of 18 doses within 1 year of treatment.
The study is designed to estimate the RR of breast cancer patients to weekly paclitaxel chemotherapy and to determine the RR to weekly PC combination chemotherapy in patients resistant to or with poor response (including early progression) while on weekly single agent paclitaxel.
- Being tested
- Paclitaxel, Perjeta, Herceptin SC, Tamoxifen, Letrozole
- Keywords
- Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III, Paclitaxel, Taxol
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaclitaxelDrug
Also called Taxol
Administered to all patients for a minimum of 8 doses with a possible maximum of 16 doses.
PerjetaDrug
Also called Pertuzumab
Only administered to patients with HER2-positive disease.
Herceptin SCDrug
Also called Trastuzumab
Only administered to patients with HER2-positive disease.
TamoxifenDrug
Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
LetrozoleDrug
Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
LHRH agonistDrug
Administered to all premenopausal patients.
FECDrug
Only administered to patients who received paclitaxel and carboplatin, and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).
CarboplatinDrug
Only administered to patients who receive paclitaxel and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel | Experimental | Investigators plan to treat patients with paclitaxel weekly for a total of approximately 16 weeks (8 weeks before ultrasonography for response assessment and 8 weeks before surgery in good responders). Paclitaxel 80mg/m2 will be given on days 1, 8, 15 and so on for a total of 8 doses. Receives: Drug: Paclitaxel |
| Carboplatin | Other | After first 8 weeks of paclitaxel, those with progressive disease (based on breast US assessment) or partial response but inoperable will have carboplatin added to their regimen. Patients will receive 8 cycles of weekly paclitaxel and carboplatin (PC). Receives: Drug: Carboplatin |
| Fluorouracil Epirubicin Hydrochloride Cyclophonsphamide (FEC) | Other | Patients with poor response to 8 courses of paclitaxel followed by 8 courses of PC based on ultrasound assessment will be regarded as failing to respond to treatment. These patients will receive 4 cycles of 3-weekly FEC and will be followed up. Receives: Drug: FEC |
| LHRH (luteinizing hormone-releasing hormone) | Other | All Premenopausal patients will receive LHRH agonist for two years for contraception and fertility preservation. Receives: Drug: LHRH agonist |
| Tamoxifen or letrozole | Other | Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Receives: Drug: Tamoxifen; Drug: Letrozole |
| Herceptin SC and Perjeta | Other | Patients with HER2-positive disease (see glossary and section 10.3) will receive 5 three-weekly courses of trastuzumab (Herceptin SC) with pertuzumab (Perjeta). After that pts will continue receiving trastuzumab to complete total of 18 doses within 1 year of treatment. Receives: Drug: Perjeta; Drug: Herceptin SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure overall clinical response rate (OCR)
OCR will be calculated as the proportion of patients with an overall response of complete clinical response (CCR) or partial clinical response (PCR), where tumor response is based on change in tumor diameter after treatment.
Measured: 24 months
Measure of complete pathologic response (pCR)
The absence of residual invasive disease in the breast and in the axillary lymph nodes at the completion of treatment will be measured.
Measured: 24 months
Secondary outcomes (8)
Number of participants with adverse events
Incidence and severity of adverse drug reactions (AE) and serious adverse drug reactions (SAE) including clinical laboratory values, vital signs, ECGs and dose interruptions.
Measured: 24 months
Time until progression free survival (PFS)
Measured: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 100 months
Duration of response (DOR)
Measured: From first reponse to the date of first documented disease progression, assessed up to 24 months
Analysis of changes from baseline using the quality of life (QoL) instrument
The various domains of QoL over time and the changes from baseline using the validated (by the European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module).
Measured: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 100 months.
To assess the genetic and epigenetic factors associated with breast cancer in Nigeria
Through correlative study of molecular markers and tumor subtypes/tumor biology with patient's characteristics, response to treatment and patients' outcome
Measured: From start date of therapy to the date of death from any cause, assessed up to 100 months
Blood concentrations of Perjeta before each dose of Perjeta/Herceptin/paclitaxel/PC
To determine the profile of Perjeta given in combination with Herceptin SC, paclitaxel and paclitaxel + carboplatinum
Measured: 24 months
Blood concentrations of Herceptin SC before each dose of Herceptin/paclitaxel/PC
To determine the profile of Herceptin SC given in combination with Perjeta, paclitaxel and PC
Measured: 24 months
Analysis of hormone recepters (ER and PgR) and HER2
To determine the pattern of response to weekly paclitaxel and PC in combination with hormone therapy or with H/Ptz dual anti-HER2 blockade based on status of clinical markers ! Hormone receptors (ER and PgR) and HER2, and other markers.
Measured: Through study completion an average of two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startNov 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionJun 2019 (estimated)
Why it stopped: Study never activated to enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olufunmilayo I. Olopade, MD, Principal investigator, University of Chicago Center for Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058939
- Sponsor's protocol ID
- IRB15-1005
- Status last verified
- Apr 2019
- First submitted
- 2 Feb 2017
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the REsponse Rate of Weekly Neo-adjuvanT pacliTAxel (Taxol) in Nigerian Women With Breast Cancer (ARETTA)
- ClinicalTrials.gov ID
- NCT03058939
- Acronym / sponsor ID
- IRB15-1005
- Keywords
- Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III, Paclitaxel, Taxol
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never activated to enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jun 2019 (estimated)
- First posted
- 23 Feb 2017 (actual)
- 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 is a two-stage phase II study with a single arm design. It will be conducted in women with breast cancer with stages IIA to IIIC (defined by AJCC 2009 classification) of all histological subtypes. All patients will receive 16 doses of paclitaxel; three breast ultrasound tests and tumor pathologic response evaluation will be used to assess the response to treatment.
Detailed description
Each patient will be assigned one of the following groups: 1) complete response, 2) partial response, 3) stable disease, 4) progressive disease, 5) early death from malignant disease, 6) early death from toxicity, 7) early death because of other cause, or 8) unknown (not assessable, insufficient data). Patients with a good response to 8 doses of paclitaxel (complete response or partial response that are operable) will receive an additional 8 courses of paclitaxel chemotherapy before surgery and radiotherapy. The overall response for these patients will be assessed by ultrasonography after a total of 16 weeks of Taxol therapy. Patients with poor response (defined as stable disease or progressive disease or partial response inoperable) as best response after eight weekly courses of paclitaxel will receive 8 cycles of weekly PC. The overall response for these patients will also be assessed by ultrasonography after 8 courses of PC therapy. Patients with poor response to 8 courses of paclitaxel followed by 8 courses of PC based on ultrasound assessment will be regarded as failing to respond to treatment. These patients will receive 4 cycles of 3-weekly FEC and will be followed up. Patients in response groups 4-8 above will be considered as failing to respond to treatment.
All conclusions will be based on all eligible patients. The schema for the study is presented in Figures 4-1, 4-2 and 4-3. Patients with a global deterioration of health status requiring discontinuation of treatment without objective evidence of disease progression at that time will be classified as having "symptomatic deterioration". Every effort will be made to document the objective progression even after discontinuation of treatment. All Premenopausal patients will receive LHRH agonist for two years for contraception and fertility preservation. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors ER and PgR (see glossary and section 10.3) and according to the state of primary menopause (see glossary) at the onset of the study. Patients with HER2-positive disease (see glossary and section 10.3) will receive 5 threeweekly courses of trastuzumab (Herceptin SC) with pertuzumab (Perjeta). After that pts will continue receiving trastuzumab to complete total of 18 doses within 1 year of treatment.
The study is designed to estimate the RR of breast cancer patients to weekly paclitaxel chemotherapy and to determine the RR to weekly PC combination chemotherapy in patients resistant to or with poor response (including early progression) while on weekly single agent paclitaxel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel | Experimental | Drug: PaclitaxelInvestigators plan to treat patients with paclitaxel weekly for a total of approximately 16 weeks (8 weeks before ultrasonography for response assessment and 8 weeks before surgery in good responders). Paclitaxel 80mg/m2 will be given on days 1, 8, 15 and so on for a total of 8 doses. |
| Carboplatin | Other | Drug: CarboplatinAfter first 8 weeks of paclitaxel, those with progressive disease (based on breast US assessment) or partial response but inoperable will have carboplatin added to their regimen. Patients will receive 8 cycles of weekly paclitaxel and carboplatin (PC). |
| Fluorouracil Epirubicin Hydrochloride Cyclophonsphamide (FEC) | Other | Drug: FECPatients with poor response to 8 courses of paclitaxel followed by 8 courses of PC based on ultrasound assessment will be regarded as failing to respond to treatment. These patients will receive 4 cycles of 3-weekly FEC and will be followed up. |
| LHRH (luteinizing hormone-releasing hormone) | Other | Drug: LHRH agonistAll Premenopausal patients will receive LHRH agonist for two years for contraception and fertility preservation. |
| Tamoxifen or letrozole | Other | Drug: Tamoxifen, Drug: LetrozoleHormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. |
| Herceptin SC and Perjeta | Other | Drug: Perjeta, Drug: Herceptin SCPatients with HER2-positive disease (see glossary and section 10.3) will receive 5 three-weekly courses of trastuzumab (Herceptin SC) with pertuzumab (Perjeta). After that pts will continue receiving trastuzumab to complete total of 18 doses within 1 year of treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Women ages of 18 to 70 years old.
- Biopsy-accessible breast tumor of significant size for core needle biopsy (≥ 2cm).
- Patients with histologically confirmed carcinoma of the female breast with any or unknown HRs/HER2 status
- Clinical stages IIA -IIIC. (AJCC 2009) (Appendix A)
- Chemotherapy-naïve patients (for this malignancy)
Key exclusion criteria (9 listed)
- Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Patients will agree to continue the use of acceptable form of contraception for 30 days from the date of last drug administration.
- Patients with brain metastasis.
- Serious, uncontrolled, concurrent infection(s).
- Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy. Patient who have received tamoxifen or raloxifene for purposes of chemoprevention (e.g. Breast Cancer Prevention Trial or for other past indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy will be discontinued at least one month before the patient is enrolled on this study.
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 |
|---|---|---|
| PaclitaxelAlso: TaxolAdministered to all patients for a minimum of 8 doses with a possible maximum of 16 doses. | Drug | Paclitaxel |
| PerjetaAlso: PertuzumabOnly administered to patients with HER2-positive disease. | Drug | Herceptin SC and Perjeta |
| Herceptin SCAlso: TrastuzumabOnly administered to patients with HER2-positive disease. | Drug | Herceptin SC and Perjeta |
| TamoxifenOnly administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. | Drug | Tamoxifen or letrozole |
| LetrozoleOnly administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. | Drug | Tamoxifen or letrozole |
| LHRH agonistAdministered to all premenopausal patients. | Drug | LHRH (luteinizing hormone-releasing hormone) |
| FECOnly administered to patients who received paclitaxel and carboplatin, and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). | Drug | Fluorouracil Epirubicin Hydrochloride Cyclophonsphamide (FEC) |
| CarboplatinOnly administered to patients who receive paclitaxel and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). | Drug | Carboplatin |
Primary outcome
Measure overall clinical response rate (OCR)
Time frame: 24 months
OCR will be calculated as the proportion of patients with an overall response of complete clinical response (CCR) or partial clinical response (PCR), where tumor response is based on change in tumor diameter after treatment.
Measure of complete pathologic response (pCR)
Time frame: 24 months
The absence of residual invasive disease in the breast and in the axillary lymph nodes at the completion of treatment will be measured.
8 secondary outcomes
Number of participants with adverse events
Time frame: 24 months
Time until progression free survival (PFS)
Time frame: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 100 months
Duration of response (DOR)
Time frame: From first reponse to the date of first documented disease progression, assessed up to 24 months
Analysis of changes from baseline using the quality of life (QoL) instrument
Time frame: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 100 months.
To assess the genetic and epigenetic factors associated with breast cancer in Nigeria
Time frame: From start date of therapy to the date of death from any cause, assessed up to 100 months
Blood concentrations of Perjeta before each dose of Perjeta/Herceptin/paclitaxel/PC
Time frame: 24 months
Blood concentrations of Herceptin SC before each dose of Herceptin/paclitaxel/PC
Time frame: 24 months
Analysis of hormone recepters (ER and PgR) and HER2
Time frame: Through study completion an average of two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
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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.
Olufunmilayo I. Olopade, MD principal investigator
University of Chicago Center for Global 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 Paclitaxel, Perjeta and Herceptin SC in people with Breast Cancer and Breast Cancer Stage II, run by University of Chicago at 1 site in Nigeria.
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 15 inclusion and 9 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: withdrawn, as of the sponsor's last update on 22 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 Nigeria. 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 withdrawn before enrolling participants, so there are no results.
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?
Measure overall clinical response rate (OCR) (time frame: 24 months). The study lists 2 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 22 Apr 2019.