Carcinoma, Intraductal, NoninfiltratingPhase 3TAM-01NCT01357772
Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up
A Phase 3 study testing Tamoxifen in people with Carcinoma, Intraductal, Noninfiltrating and Recurrence, Local Neoplasm, run by Andrea DeCensi at 14 sites in Italy.
Trial summary
The aim of the study is to evaluate whether tamoxifen at a low dose of 5mg/d reduces in the long term the incidence of invasive breast cancer and ductal carcinoma in situ, DCIS (DIN 1c, 2, 3) of the breast, in woman operated for lobular intraepithelial neoplasia (LIN1, 2 and 3) or ER-positive ductal intraepithelial… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Carcinoma, Intraductal, Noninfiltrating, Recurrence, Local Neoplasm, Breast Neoplasms
- What is being tested?
- Tamoxifen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 14 sitesItaly
- Study dates
- 12 Nov 2008to 31 Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women of age ≥ 18 and < 75 years
- Women operated on for lobular (LIN 2 and 3) or ER positive or unknown ductal DCIS, i.e DIN 1-3, but DIN 1a excluded) intraepithelial neoplasia in the 5 years (60 months) prior the inclusion in the study. Both incident (diagnosis < 12 months) and prevalent cases diagnosis ≥12, and < 60 months) will be included, including recurrent cases
- ECOG Performance status ≤ 1
- Written informed consent
Who cannot join
- Any type of malignancy, with the exclusion of non-melanoma skin cancer
- Proliferative disorders of the endometrium such as atypical hyperplasia, endometriosis, unresected polyps, symptomatic myoma
- Liver, kidney and heart function impairment grade ≥ 2 (CTCAE criteria v.3.0)
- Any type of retinal disorders, severe cataract and glaucoma
- Presence of significant risk factors for venous events, including immobilization after trauma within the last 3 months for longer than 2 weeks, deep venous thrombophlebitis or other significant venous thrombotic event,VTE (pulmonary embolism, stroke, etc.)
- Use of tamoxifen, raloxifene or other selective estrogen receptor modulator (SERMs)
Show all 13Show fewer
- Use of anastrozole and other aromatase inhibitors (AI) in the last 12 months for ≥ 6 months
- Dicoumarol anticoagulant therapy in progress
- Active infections
- Severe psychiatric disorders or inability to comply to the protocol procedures
- Geographic inaccessibility or difficulties in ensuring adequate compliance
- Women who are pregnant or breastfeeding
- Any other factor which, at the discretion of the investigator, may controindicate the use of tamoxifen
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites
IRCCS Istituto Tumori Giovanni Paolo II
Bari, 70124
Ospedale di Carpi "Bernardino Ramazzini"
Carpi, Modena, 41012
Azienda Ospedaliera Mater Domini Catanzaro
Catanzaro, 88100
E.O. Ospedali Galliera
Genoa, 16128
Istituto Scientifico Romagnolo per lo studio e la cura dei tumori
Meldola, Forlì-Cesena, 47521
IEO - European Institute of Oncology IRCCS
Milan, 20100
Azienda Ospedaliera-Universitaria Policlinico di Modena
Modena, 41100
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale
Naples, 80131
ICS Maugeri -Centro Medico di Pavia
Pavia
AUSL - Oncologia Medica
Ravenna, 48018
Azienda Ospedaliera-Universitaria Città della Salute e della Scienza di Torino
Torino, 10123
Ospedali riuniti ASL AL - Ospedale SS. Antonio e Margherita
Tortona, Alessandria, 15057
Azienda Socio-Sanitaria Territoriale Sette Laghi, Varese
Varese, 21100
Azienda ULSS8 Berica
Vicenza, 36100
About this study
Official title: Randomized Placebo-controlled Phase III Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up
The aim of the study is to evaluate whether tamoxifen at a low dose of 5mg/d reduces in the long term the incidence of invasive breast cancer and ductal carcinoma in situ, DCIS (DIN 1c, 2, 3) of the breast, in woman operated for lobular intraepithelial neoplasia (LIN1, 2 and 3) or ER-positive ductal intraepithelial neoplasia (DIN 1b, DIN2, DIN3, 1a excluded) of the breast.
To improve the risk-benefit ratio, the use of lower doses of the drug has been proposed.
Read more
Biomarker trials revealed that 5 mg/d was noninferior to 20 mg/d in inhibiting proliferation of breast cancer and normal endometrial tissue.
By contrast, the risk of endometrial cancer si dose-dependent, and the dose reduction can lead a substantial decrease. Morover a dose of 5 mg/day is associated with an overall decrease of the estrogenic activity of tamoxifen on insulin like growth factor (IGF-I), sex hormone-binding globulin (SHBG) and antithrombin-III, with a decrease of venous thromboembolic events. Moreover, tamoxifen exhibits a high tissue distribution, so that a dose of 5 mg/day attains at the breast tissue level a concentration 10 times higher than that needed to inhibit cell growth in vitro.
A prospective cohort study also showed that 10 mg on alternate days halves recurrence of DCIS in postmenopausal women.
It has been shown that the treatment of dysplasia or pre-cancer drives the reduction of the invasive neoplasms onset. This is a chemoprevention trial designed to validatate the low-dose Tamoxifen in women with diseases at high evolutionary risk. The demonstration of efficacy and safety of such a treatment for the prevention of the invasive breast cancer would lead improvements in term of survival and quality of life for the patients at increased risk.
Read the detailed description
Italian, multicenter, phase III trial: controlled, parallel group comparision, randomized (1:1) duble blind, tamoxifen 5 mg/d versus placebo administered for 3 years. A total of 500 women 75 years of age or younger with newly diagnosed non-invasive breast cancer have been included in the study. The long-term study implies a minimum 10 year follow up after treatment completion.
- Conditions
- Carcinoma, Intraductal, Noninfiltrating, Recurrence, Local Neoplasm, Breast Neoplasms, Atypical Hyperplasia
- Being tested
- Tamoxifen, placebo
- Keywords
- DCIS, tamoxifen, dose reduction
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Neoplasm Recurrence, Local, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Also called Tamoxifen citrate (ATC code: L02BA01)
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen | Experimental | tamoxifen at daily dose of 5 mg for a total treatment time of 3 years Receives: Drug: Tamoxifen |
| placebo | Placebo comparator | placebo at daily dose of 5 mg for a total treatment time of 3 years Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of invasive breast cancer events and DCIS
Number of neoplastic events, i.e., invasive breast cancer or ductal carcinoma in situ of the breast from the start of treatment up to at least 16 years from treatment initiation.
Measured: 20 years
Secondary outcomes (3)
Number of other non-invasive breast events
Number of other non-invasive breast disorders (LCIS, atypical ductal or lobular hyperplasia), endometrial cancer, ovarian cancer, thromboembolic events; bone fractures, cardiovascular and thromboembolic events, clinically manifested cataracts and melanoma; change of mammographic density from the start of treatment up to at least 16 years from treatment initiation.
Measured: 20 years
Metabolites of tamoxifen and hormone blood level (in a subgroup of women)
Blood concentrations of metabolites including circulating IGF-I,IGFBP-3, SHBG, hormones (testosterone, estradiol, SHBG, CRP), tamoxifen metabolites (4OH tamoxifen and endoxifen).
Measured: 20 years
CYP2D6 polymorphisms analysis
Esploratory analisis of some SNPS of the cytochrome P450 genes involved in tamoxifen metabolism such as CYP2D6.
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study start12 Nov 2008
- Primary completion31 Dec 2022
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Intraductal, NoninfiltratingStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea DeCensi
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, European Institute of Oncology
- Responsible party
- Sponsor-investigator, Andrea DeCensi, Ente Ospedaliero Ospedali Galliera
- Investigators
- Andrea DeCensi, MD, Principal investigator, E.O.Ospedali Galliera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357772
- Sponsor's protocol ID
- GAL 01
- Other IDs
- 2007-007740-10
- Acronym
- TAM-01
- Status last verified
- Jul 2023
- First submitted
- 17 May 2011
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Authors are open to share data based on a request for collaboration that includes a data analysis plan. Please send an e-mail to both: andrea.decensi@galliera.it; mpuntoni@ao.pr.it
Publications
DeCensi A, Puntoni M, Johansson H, Guerrieri-Gonzaga A, Caviglia S, Avino F, Cortesi L, Ponti A, Pacquola MG, Falcini F, Gulisano M, Digennaro M, Cariello A, Cagossi K, Pinotti G, Lazzeroni M, Serrano D, Briata IM, Buttiron Webber T, Boni L, Bonanni B. Effect Modifiers of Low-Dose Tamoxifen in a Randomized Trial in Breast Noninvasive Disease. Clin Cancer Res. 2021 Jul 1;27(13):3576-3583. doi: 10.1158/1078-0432.CCR-20-4213. Epub 2021 Feb 19.
PubMed 33608319Lazzeroni M, Serrano D, Dunn BK, Heckman-Stoddard BM, Lee O, Khan S, Decensi A. Oral low dose and topical tamoxifen for breast cancer prevention: modern approaches for an old drug. Breast Cancer Res. 2012 Oct 29;14(5):214. doi: 10.1186/bcr3233.
PubMed 23106852DeCensi A, Johansson H, Helland T, Puntoni M, Macis D, Aristarco V, Caviglia S, Webber TB, Briata IM, D'Amico M, Serrano D, Guerrieri-Gonzaga A, Bifulco E, Hustad S, Soiland H, Boni L, Bonanni B, Mellgren G. Association of CYP2D6 genotype and tamoxifen metabolites with breast cancer recurrence in a low-dose trial. NPJ Breast Cancer. 2021 Mar 25;7(1):34. doi: 10.1038/s41523-021-00236-6.
PubMed 33767162Lazzeroni M, Puntoni M, Guerrieri-Gonzaga A, Serrano D, Boni L, Buttiron Webber T, Fava M, Briata IM, Giordano L, Digennaro M, Cortesi L, Falcini F, Serra P, Avino F, Millo F, Cagossi K, Gallerani E, De Simone A, Cariello A, Aprile G, Renne M, Bonanni B, DeCensi A. Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Recurrence in Breast Noninvasive Neoplasia: A 10-Year Follow-Up of TAM-01 Study. J Clin Oncol. 2023 Jun 10;41(17):3116-3121. doi: 10.1200/JCO.22.02900. Epub 2023 Mar 14.
PubMed 36917758DeCensi A, Puntoni M, Guerrieri-Gonzaga A, Caviglia S, Avino F, Cortesi L, Taverniti C, Pacquola MG, Falcini F, Gulisano M, Digennaro M, Cariello A, Cagossi K, Pinotti G, Lazzeroni M, Serrano D, Branchi D, Campora S, Petrera M, Buttiron Webber T, Boni L, Bonanni B. Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia. J Clin Oncol. 2019 Jul 1;37(19):1629-1637. doi: 10.1200/JCO.18.01779. Epub 2019 Apr 11.
PubMed 30973790
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Phase III Trial of Low Dose Tamoxifen in Women With Breast Intraepithelial Neoplasia - Long Term Follow-up
- ClinicalTrials.gov ID
- NCT01357772
- Acronym / sponsor ID
- TAM-01 / GAL 01
- Conditions
- Carcinoma, Intraductal, Noninfiltrating, Recurrence, Local Neoplasm, Breast Neoplasms, Atypical Hyperplasia
- Keywords
- DCIS, tamoxifen, dose reduction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Andrea DeCensiUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, European Institute of Oncology
- Study start
- 12 Nov 2008 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 May 2011 (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 aim of the study is to evaluate whether tamoxifen at a low dose of 5mg/d reduces in the long term the incidence of invasive breast cancer and ductal carcinoma in situ, DCIS (DIN 1c, 2, 3) of the breast, in woman operated for lobular intraepithelial neoplasia (LIN1, 2 and 3) or ER-positive ductal intraepithelial neoplasia (DIN 1b, DIN2, DIN3, 1a excluded) of the breast.
To improve the risk-benefit ratio, the use of lower doses of the drug has been proposed.
Biomarker trials revealed that 5 mg/d was noninferior to 20 mg/d in inhibiting proliferation of breast cancer and normal endometrial tissue.
By contrast, the risk of endometrial cancer si dose-dependent, and the dose reduction can lead a substantial decrease. Morover a dose of 5 mg/day is associated with an overall decrease of the estrogenic activity of tamoxifen on insulin like growth factor (IGF-I), sex hormone-binding globulin (SHBG) and antithrombin-III, with a decrease of venous thromboembolic events. Moreover, tamoxifen exhibits a high tissue distribution, so that a dose of 5 mg/day attains at the breast tissue level a concentration 10 times higher than that needed to inhibit cell growth in vitro.
A prospective cohort study also showed that 10 mg on alternate days halves recurrence of DCIS in postmenopausal women.
It has been shown that the treatment of dysplasia or pre-cancer drives the reduction of the invasive neoplasms onset. This is a chemoprevention trial designed to validatate the low-dose Tamoxifen in women with diseases at high evolutionary risk. The demonstration of efficacy and safety of such a treatment for the prevention of the invasive breast cancer would lead improvements in term of survival and quality of life for the patients at increased risk.
Detailed description
Italian, multicenter, phase III trial: controlled, parallel group comparision, randomized (1:1) duble blind, tamoxifen 5 mg/d versus placebo administered for 3 years. A total of 500 women 75 years of age or younger with newly diagnosed non-invasive breast cancer have been included in the study. The long-term study implies a minimum 10 year follow up after treatment completion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen | Experimental | Drug: Tamoxifentamoxifen at daily dose of 5 mg for a total treatment time of 3 years |
| placebo | Placebo comparator | Drug: placeboplacebo at daily dose of 5 mg for a total treatment time of 3 years |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women of age ≥ 18 and < 75 years
- Women operated on for lobular (LIN 2 and 3) or ER positive or unknown ductal DCIS, i.e DIN 1-3, but DIN 1a excluded) intraepithelial neoplasia in the 5 years (60 months) prior the inclusion in the study. Both incident (diagnosis < 12 months) and prevalent cases diagnosis ≥12, and < 60 months) will be included, including recurrent cases
- ECOG Performance status ≤ 1
- Written informed consent
Key exclusion criteria (13 listed)
- Any type of malignancy, with the exclusion of non-melanoma skin cancer
- Proliferative disorders of the endometrium such as atypical hyperplasia, endometriosis, unresected polyps, symptomatic myoma
- Liver, kidney and heart function impairment grade ≥ 2 (CTCAE criteria v.3.0)
- Any type of retinal disorders, severe cataract and glaucoma
- Presence of significant risk factors for venous events, including immobilization after trauma within the last 3 months for longer than 2 weeks, deep venous thrombophlebitis or other significant venous thrombotic event,VTE (pulmonary embolism, stroke, etc.)
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 |
|---|---|---|
| TamoxifenAlso: Tamoxifen citrate (ATC code: L02BA01) | Drug | Tamoxifen |
| placebo | Drug | placebo |
Primary outcome
Number of invasive breast cancer events and DCIS
Time frame: 20 years
Number of neoplastic events, i.e., invasive breast cancer or ductal carcinoma in situ of the breast from the start of treatment up to at least 16 years from treatment initiation.
3 secondary outcomes
Number of other non-invasive breast events
Time frame: 20 years
Metabolites of tamoxifen and hormone blood level (in a subgroup of women)
Time frame: 20 years
CYP2D6 polymorphisms analysis
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Results publication: PubMed 33608319DeCensi A, Puntoni M, Johansson H, Guerrieri-Gonzaga A, Caviglia S, Avino F, Cortesi L, Ponti A, Pacquola MG, Falcini F, Gulisano M, Digennaro M, Cariello A, Cagossi K, Pinotti G, Lazzeroni M, Serrano D, Briata IM, Buttiron Webber T, Boni L, Bonanni B. Effect Modifiers of Low-Dose Tamoxifen in a Randomized Trial in Breast Noninvasive Disease. Clin Cancer Res. 2021 Jul 1;27(13):3576-3583. doi: 10.1158/1078-0432.CCR-20-4213. Epub 2021 Feb 19.
- Results publication: PubMed 23106852Lazzeroni M, Serrano D, Dunn BK, Heckman-Stoddard BM, Lee O, Khan S, Decensi A. Oral low dose and topical tamoxifen for breast cancer prevention: modern approaches for an old drug. Breast Cancer Res. 2012 Oct 29;14(5):214. doi: 10.1186/bcr3233.
- Results publication: PubMed 33767162DeCensi A, Johansson H, Helland T, Puntoni M, Macis D, Aristarco V, Caviglia S, Webber TB, Briata IM, D'Amico M, Serrano D, Guerrieri-Gonzaga A, Bifulco E, Hustad S, Soiland H, Boni L, Bonanni B, Mellgren G. Association of CYP2D6 genotype and tamoxifen metabolites with breast cancer recurrence in a low-dose trial. NPJ Breast Cancer. 2021 Mar 25;7(1):34. doi: 10.1038/s41523-021-00236-6.
- Results publication: PubMed 36917758Lazzeroni M, Puntoni M, Guerrieri-Gonzaga A, Serrano D, Boni L, Buttiron Webber T, Fava M, Briata IM, Giordano L, Digennaro M, Cortesi L, Falcini F, Serra P, Avino F, Millo F, Cagossi K, Gallerani E, De Simone A, Cariello A, Aprile G, Renne M, Bonanni B, DeCensi A. Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Recurrence in Breast Noninvasive Neoplasia: A 10-Year Follow-Up of TAM-01 Study. J Clin Oncol. 2023 Jun 10;41(17):3116-3121. doi: 10.1200/JCO.22.02900. Epub 2023 Mar 14.
- Derived from this study: PubMed 30973790DeCensi A, Puntoni M, Guerrieri-Gonzaga A, Caviglia S, Avino F, Cortesi L, Taverniti C, Pacquola MG, Falcini F, Gulisano M, Digennaro M, Cariello A, Cagossi K, Pinotti G, Lazzeroni M, Serrano D, Branchi D, Campora S, Petrera M, Buttiron Webber T, Boni L, Bonanni B. Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia. J Clin Oncol. 2019 Jul 1;37(19):1629-1637. doi: 10.1200/JCO.18.01779. Epub 2019 Apr 11.
- PubMed ID: 33608319Link provided by the sponsor.
- PubMed ID: 23106852Link provided by the sponsor.
- PubMed ID: 33767162Link provided by the sponsor.
- PMID: 36917758Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Authors are open to share data based on a request for collaboration that includes a data analysis plan. Please send an e-mail to both: andrea.decensi@galliera.it; mpuntoni@ao.pr.it
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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.
Andrea DeCensi, MD principal investigator
E.O.Ospedali Galliera
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamoxifen in people with Carcinoma, Intraductal, Noninfiltrating and Recurrence, Local Neoplasm, run by Andrea DeCensi at 14 sites in Italy.
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 4 inclusion and 13 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of invasive breast cancer events and DCIS (time frame: 20 years). 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 NCT01357772, which also lists 5 linked publications.
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 Jul 2023.