Breast CancerPhase 2NeoTOPNCT02339532
Neoadjuvant Phase II Trial in Patients With T1c Operable, HER2-positive Breast Cancer According to TOP2A Status
A Phase 2 study testing FEC100, Docetaxel and Trastuzumab in people with Breast Cancer, run by UNICANCER at 12 sites in France.
Trial summary
The main objective of this multicenter study will therefore be to evaluate pathologic complete response rates of an anthracycline-based regimen [FEC 100 - TAXOTERE® - HERCEPTIN® - PERTUZUMAB] and a non anthracycline-based regimen [TAXOTERE® - CARBOPLATINE - HERCEPTIN® - PERTUZUMAB] according to the presence or not of… 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?
- FEC100, Docetaxel and Trastuzumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 12 sitesFrance
- Study dates
- Jan 2015to 8 Jul 2024
- 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
- Women aged ≥ 18;
- Patient has histologically confirmed breast cancer, with a clinical tumour diameter of > 1 cm (cT1c, cT2-3 or T4a)-
- Any N status
- No clinically or radiologically detectable metastases (M0);
- HR negative (both ER and PR < 10% by IHC); for T1c status, otherwise HR negative or positive
- Her-2 positive (i.e. IHC score 3+ or FISH/SISH/CISH positive);
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- Performance status ≤ 1 (according to WHO criteria);
- Patients not previously treated by surgery, radiotherapy, hormone therapy or chemotherapy;
- Hæmatology: Absolute neutrophil count (ANC) ≥1,500/mm³; Platelets ≥100,000/mm³; Total white blood cell count (WBC) ≥3.000/mm³; Hb> 9g/dl;
- Hepatic Function: Total bilirubin ≤1.5 time the upper normal limit (UNL); ASAT ≤ 1.5xUNL; ALAT ≤ 1.5xUNL; Alkaline phosphatase ≤ 2.5xUNL;
- Renal Function: Serum creatinine ≤1.5xUNL (and if Serum creatinine >1.5xUNL, Creatinine clearance ≥50 mL/min (MDRD formula);
- Metabolic Function: Magnesium ≥ lower limit of normal; Calcium ≥ lower limit of normal;
- Patient with not controlled heart disease and for whom anthracyclines are not contraindicated. Cardiac ejection fraction ≥50% measured by MUGA or ECHO done within 4 weeks before inclusion;
- Patient agreeing to use effective contraception during and for ≥ 7 months after completion of study treatment;
- Patient able to comply with the protocol;
- Patient must have signed a written informed consent form prior to any study specific procedures;
- Patient must be affiliated to a Social Health Insurance.
Who cannot join
- Bilateral or multifocal breast cancer;
- Non-measurable tumour;
- Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or overlooked forms (T4b or T4d);
- HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative);
- RH positive (ER or PR ≥ 10% by IHC) ;
- Patient has a history of second cancer, with exception of in situ cervical cancer or basocellular skin cancer which is regarded as cured;
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- Patient has already been treated for new breast cancer;
- Patients have already undergone surgery for their disease or have had primary axillary dissection;
- Prior docetaxel administration or anti-HER2 antibody therapy (e.g.: trastuzumab or pertuzumab);
- Patients with other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study, such as, but not limited to:
- Heart or kidney failure, medullary, respiratory or liver failure, dyspnea
- Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia, poorly controlled hypertension) ≤ 1 year before enrollment
- Uncontrolled diabetes
- Significant neurological or psychiatric abnormalities
- Symptomatic or progressive disorder of the central nervous system (CNS) or metastasis at the initial check-up.
- Peripheral neuropathy > grade 2
- Acute urinary infection, ongoing hemorrhagic cystitis;
- Patients with a known history of HIV seropositivity;
- Sensitivity to any of the study medications or any of the ingredients or excipients of these medications;
- Patients receiving of the concomitant medications with phenytoin;
- Patients who received any other investigational drugs within 30 days of initiation of treatment and/or during the study;
- Must not have had a major surgical procedure within 30 days of initiation of treatment;
- Pregnant women, women who are likely to become pregnant or are breast-feeding;
- Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
- Patients with history of non compliance to medical regimens or unwilling or unable to comply with the protocol;
- Individual deprived of liberty or placed under the authority of a tutor.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Institut de Cancerologie de L'Ouest - Site Paul Papin
Angers
Centre Hospitalier Regional Universitaire de Brest - Hôpital Morvan
Brest
Centre Francois Baclesse
Caen
Centre Jean Perrin
Clermont-Ferrand
Chu de Grenoble - Hopital Michallon
Grenoble
Chu de Limoges - Hôpital Dupuytren
Limoges
Centre Leon Berard
Lyon
Institut Regional Du Cancer Montpellier Val D'Aurelle
Montpellier
Institut de Cancerologie de L'Ouest - Site Rene Gauducheau
Saint-Herblain
Hopital D'Instructions Des Armees
Saint-Mandé
Centre Paul Strauss
Strasbourg
Institut de Cancerologie de Lorraine Alexis Vautrin
Vandœuvre-lès-Nancy
About this study
Official title: Neoadjuvant Phase II Trial Combining [3 FEC 100 Followed by 3 Docetaxel Associated With Trastuzumab Plus Pertuzumab] or [6 Docetaxel, Carboplatin Associated With Trastuzumab Plus Pertuzumab] According to TOP2A Status in Patients With T1c Operable, HER2-positive Breast Cancer
The main objective of this multicenter study will therefore be to evaluate pathologic complete response rates of an anthracycline-based regimen [FEC 100 - TAXOTERE® - HERCEPTIN® - PERTUZUMAB] and a non anthracycline-based regimen [TAXOTERE® - CARBOPLATINE - HERCEPTIN® - PERTUZUMAB] according to the presence or not of TOP2A gene amplification in a population of breast cancer patients with HER2 overexpression.
A very important objective of the study will be the evaluation of biomarkers that predict response to treatment.
Read the detailed description
In this phase II study, we propose a treatment strategy that not only takes advantage of the complementary action of trastuzumab and pertuzumab but also the relevance of an anthracycline-based regimen. Indeed, besides the cardiac toxicity that can be induced by these three agents, anthracycline chemotherapy may not confer benefit to all patients.
The underlying scientific hypothesis is based on data from the NEOSPHERE neoadjuvant trial showing that addition of pertuzumab to trastuzumab plus docetaxel improved the pCR rate (46% versus 29% without pertuzumab) in T2-T3 tumors. Therefore, we hypothesize that for smaller tumors (T1c), the pCR rate should be higher, on the order of 60% in patients with the coamplification (with anthracycline therapy) and 55% for the group without coamplification (without anthracycline therapy). The sample size of 90 patients (45 per group) planned for the phase II study will allow 15% precision with the expected pCR rates of 60% (95%CI: 45%-75%) for patients with coamplification and 55% (95%CI: 40%-70%) for those without coamplification. In addition, exploratory analyses will aim to identify predictive markers of pCR in order to target biologically defined subpopulations in which pCR rates might even be higher.
- Conditions
- Breast Cancer
- Being tested
- FEC100, Docetaxel, Trastuzumab, Pertuzumab, Carboplatin
- Keywords
- HER2-positive, non-metastatic, TOP2A
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEC100Drug
3 cycles of FEC 100 administered IV q3w
- 5-Fluorouracil (5-FU) 500 mg/m²
- Epirubicin 100 mg/m²
- Cyclophosphamide 500 mg/m²
DocetaxelDrug
TOP2A amplified : DOCETAXEL 75 mg/m² IV escalating at 100 mg/m² IV as tolerated q3w TOP2A not amplified : DOCETAXEL 75 mg/m² IV
TrastuzumabDrug
Trastuzumab 8 mg/kg loading dose administered intravenously (IV) followed by 6 mg/kg IV q3w in subsequent cycles.
PertuzumabDrug
Pertuzumab 840 mg loading dose administered IV followed by 420 mg IV q3w in subsequent cycles.
CarboplatinDrug
CARBOPLATIN AUC 6 IV q3w
| Study group | Role | What they receive |
|---|---|---|
| TOP2A amplified | Experimental | If TOP2A amplified: FEC x 3 then THP x 3 3 cycles of FEC 100 administered IV q3w
* 5-Fluorouracil (5-FU) 500 mg/m²
* Epirubicin 100 mg/m²
* Cyclophosphamide 500 mg/m²
Followed by 3 cycles of Trastuzumab-Pertuzumab-Docetaxel:
* Trastuzumab 8 mg/kg loading dose administered intravenously (IV) followed by 6 mg/kg IV q3w in subsequent cycles.
* Pertuzumab 840 mg loading dose administered IV followed by 420 mg IV q3w in subsequent cycles.
* DOCETAXEL 75 mg/m² IV escalating at 100 mg/m² IV as tolerated q3w Receives: Drug: FEC100; Drug: Docetaxel; Drug: Trastuzumab; Drug: Pertuzumab |
| TOP2A not amplified | Experimental | If TOP2A not amplified: TCHP x 6 TCHP administered IV q3w for 6 cycles
* Trastuzumab 8 mg/kg loading dose administered IV followed by 6 mg/kg IV q3w in subsequent cycles.
* Pertuzumab 840 mg loading dose administered IV followed by 420 mg IV q3w in subsequent cycles.
* DOCETAXEL 75 mg/m² IV q3w
* CARBOPLATIN AUC 6 IV q3w
The Calvert formula will be used to calculate the dose of carboplatin:
Dose (mg) = target AUC (mg/mL x min) x [GFR mL/min + 25] Dose (mg) = 6 x [GFR mL/min + 25] NOTE: the Calvert formula gives the dose in mg, not mg/m². GFR, glomerular filtration rate The maximum dose of CARBOPLATIN must not exceed 900 mg. Receives: Drug: Docetaxel; Drug: Trastuzumab; Drug: Pertuzumab; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response according to Chevallier classification
on surgical specimen and lymph nodes at the time of the surgery
Measured: 20 weeks
Secondary outcomes (6)
Predictive factors of response to both treatment regimens (anthracycline-based and non anthracycline-based regimens)
on surgical specimen and lymph nodes at the time of the surgery
Measured: 20 weeks
Pathological complete response (pCR), according to Sataloff's classification
on surgical specimen and lymph nodes at the time of the surgery
Measured: 20 weeks
Clinical and radiological response according to the WHO criteria
on mammography and breast echography
Measured: after two cycles of treatment and after the end of treatment
Toxicity according to NCI CTC-AE v4.0 criteria
according the occurrence of adverse events and toxicities assessed every week
Measured: during on-treatment period (defined as the period from the first dose of study medication up to 30 days of the last dose
Progression-free survival
The PFS is defined as the time from the first administration of treatment to progression or death of any cause, if progression has not been documented.
Measured: up to 60 months
Overall survival
The OS is defined as the time from the first administration of treatment to death from any cause.
Measured: up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2015 (estimated)
- Study startJan 2015
- Primary completion7 Oct 2019
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Ange MOURET REYNIER, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02339532
- Sponsor's protocol ID
- GEP13
- Acronym
- NeoTOP
- Status last verified
- Nov 2024
- First submitted
- 14 Dec 2014
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ginzac A, Molnar I, Durando X, Motte Rouge T, Petit T, D'hondt V, Campone M, Bonichon-Lamichhane N, Venat Bouvet L, Levy C, Augereau P, Pistilli B, Arsene O, Jouannaud C, Nguyen S, Cayre A, Tixier L, Mahier Ait Oukhatar C, Nabholtz JM, Penault-Llorca F, Mouret-Reynier MA. Neoadjuvant anthracycline-based (5-FEC) or anthracycline-free (docetaxel/carboplatin) chemotherapy plus trastuzumab and pertuzmab in HER2 + BC patients according to their TOP2A: a multicentre, open-label, non-randomized phase II trial. Breast Cancer Res Treat. 2024 Jun;205(2):267-279. doi: 10.1007/s10549-024-07285-y. Epub 2024 Mar 7.
PubMed 38453781
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Phase II Trial Combining [3 FEC 100 Followed by 3 Docetaxel Associated With Trastuzumab Plus Pertuzumab] or [6 Docetaxel, Carboplatin Associated With Trastuzumab Plus Pertuzumab] According to TOP2A Status in Patients With T1c Operable, HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT02339532
- Acronym / sponsor ID
- NeoTOP / GEP13
- Conditions
- Breast Cancer
- Keywords
- HER2-positive, non-metastatic, TOP2A
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 7 Oct 2019 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 15 Jan 2015 (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.
The main objective of this multicenter study will therefore be to evaluate pathologic complete response rates of an anthracycline-based regimen [FEC 100 - TAXOTERE® - HERCEPTIN® - PERTUZUMAB] and a non anthracycline-based regimen [TAXOTERE® - CARBOPLATINE - HERCEPTIN® - PERTUZUMAB] according to the presence or not of TOP2A gene amplification in a population of breast cancer patients with HER2 overexpression.
A very important objective of the study will be the evaluation of biomarkers that predict response to treatment.
Detailed description
In this phase II study, we propose a treatment strategy that not only takes advantage of the complementary action of trastuzumab and pertuzumab but also the relevance of an anthracycline-based regimen. Indeed, besides the cardiac toxicity that can be induced by these three agents, anthracycline chemotherapy may not confer benefit to all patients.
The underlying scientific hypothesis is based on data from the NEOSPHERE neoadjuvant trial showing that addition of pertuzumab to trastuzumab plus docetaxel improved the pCR rate (46% versus 29% without pertuzumab) in T2-T3 tumors. Therefore, we hypothesize that for smaller tumors (T1c), the pCR rate should be higher, on the order of 60% in patients with the coamplification (with anthracycline therapy) and 55% for the group without coamplification (without anthracycline therapy). The sample size of 90 patients (45 per group) planned for the phase II study will allow 15% precision with the expected pCR rates of 60% (95%CI: 45%-75%) for patients with coamplification and 55% (95%CI: 40%-70%) for those without coamplification. In addition, exploratory analyses will aim to identify predictive markers of pCR in order to target biologically defined subpopulations in which pCR rates might even be higher.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOP2A amplified | Experimental | Drug: FEC100, Drug: Docetaxel, Drug: Trastuzumab, Drug: PertuzumabIf TOP2A amplified: FEC x 3 then THP x 3 3 cycles of FEC 100 administered IV q3w * 5-Fluorouracil (5-FU) 500 mg/m² * Epirubicin 100 mg/m² * Cyclophosphamide 500 mg/m² Followed by 3 cycles of Trastuzumab-Pertuzumab-Docetaxel: * Trastuzumab 8 mg/kg loading dose administered intravenously (IV) followed by 6 mg/kg IV q3w in subsequent cycles. * Pertuzumab 840 mg loading dose administered IV followed by 420 mg IV q3w in subsequent cycles. * DOCETAXEL 75 mg/m² IV escalating at 100 mg/m² IV as tolerated q3w |
| TOP2A not amplified | Experimental | Drug: Docetaxel, Drug: Trastuzumab, Drug: Pertuzumab, Drug: CarboplatinIf TOP2A not amplified: TCHP x 6 TCHP administered IV q3w for 6 cycles * Trastuzumab 8 mg/kg loading dose administered IV followed by 6 mg/kg IV q3w in subsequent cycles. * Pertuzumab 840 mg loading dose administered IV followed by 420 mg IV q3w in subsequent cycles. * DOCETAXEL 75 mg/m² IV q3w * CARBOPLATIN AUC 6 IV q3w The Calvert formula will be used to calculate the dose of carboplatin: Dose (mg) = target AUC (mg/mL x min) x [GFR mL/min + 25] Dose (mg) = 6 x [GFR mL/min + 25] NOTE: the Calvert formula gives the dose in mg, not mg/m². GFR, glomerular filtration rate The maximum dose of CARBOPLATIN must not exceed 900 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Women aged ≥ 18;
- Patient has histologically confirmed breast cancer, with a clinical tumour diameter of > 1 cm (cT1c, cT2-3 or T4a)-
- Any N status
- No clinically or radiologically detectable metastases (M0);
- HR negative (both ER and PR < 10% by IHC); for T1c status, otherwise HR negative or positive
Key exclusion criteria (26 listed)
- Bilateral or multifocal breast cancer;
- Non-measurable tumour;
- Any form of breast cancer other than those described in the inclusion criteria, particularly inflammatory and/or overlooked forms (T4b or T4d);
- HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative);
- RH positive (ER or PR ≥ 10% by IHC) ;
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 |
|---|---|---|
| FEC1003 cycles of FEC 100 administered IV q3w * 5-Fluorouracil (5-FU) 500 mg/m² * Epirubicin 100 mg/m² * Cyclophosphamide 500 mg/m² | Drug | TOP2A amplified |
| DocetaxelTOP2A amplified : DOCETAXEL 75 mg/m² IV escalating at 100 mg/m² IV as tolerated q3w TOP2A not amplified : DOCETAXEL 75 mg/m² IV | Drug | TOP2A amplified, TOP2A not amplified |
| TrastuzumabTrastuzumab 8 mg/kg loading dose administered intravenously (IV) followed by 6 mg/kg IV q3w in subsequent cycles. | Drug | TOP2A amplified, TOP2A not amplified |
| PertuzumabPertuzumab 840 mg loading dose administered IV followed by 420 mg IV q3w in subsequent cycles. | Drug | TOP2A amplified, TOP2A not amplified |
| CarboplatinCARBOPLATIN AUC 6 IV q3w | Drug | TOP2A not amplified |
Primary outcome
Pathological complete response according to Chevallier classification
Time frame: 20 weeks
on surgical specimen and lymph nodes at the time of the surgery
6 secondary outcomes
Predictive factors of response to both treatment regimens (anthracycline-based and non anthracycline-based regimens)
Time frame: 20 weeks
Pathological complete response (pCR), according to Sataloff's classification
Time frame: 20 weeks
Clinical and radiological response according to the WHO criteria
Time frame: after two cycles of treatment and after the end of treatment
Toxicity according to NCI CTC-AE v4.0 criteria
Time frame: during on-treatment period (defined as the period from the first dose of study medication up to 30 days of the last dose
Progression-free survival
Time frame: up to 60 months
Overall survival
Time frame: up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Derived from this study: PubMed 38453781Ginzac A, Molnar I, Durando X, Motte Rouge T, Petit T, D'hondt V, Campone M, Bonichon-Lamichhane N, Venat Bouvet L, Levy C, Augereau P, Pistilli B, Arsene O, Jouannaud C, Nguyen S, Cayre A, Tixier L, Mahier Ait Oukhatar C, Nabholtz JM, Penault-Llorca F, Mouret-Reynier MA. Neoadjuvant anthracycline-based (5-FEC) or anthracycline-free (docetaxel/carboplatin) chemotherapy plus trastuzumab and pertuzmab in HER2 + BC patients according to their TOP2A: a multicentre, open-label, non-randomized phase II trial. Breast Cancer Res Treat. 2024 Jun;205(2):267-279. doi: 10.1007/s10549-024-07285-y. Epub 2024 Mar 7.
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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.
Marie-Ange MOURET REYNIER principal investigator
Centre Jean Perrin
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FEC100, Docetaxel and Trastuzumab in people with Breast Cancer, run by UNICANCER at 12 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 26 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: finished, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pathological complete response according to Chevallier classification (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02339532, which also lists 1 linked publication.
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 8 Nov 2024.