Breast CancerROYALNCT07151911
Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients
An observational study of Breast Cancer, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
The primary goal of this observational study is to describe the distribution of treatment options and patients' characteristics according to the definition of high-risk status in the early breast cancer (EBC) setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- abemaciclib, olaparib and endocrine therapy
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 26 Aug 2024to Sep 2031
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High-risk HR positive, HER2 negative, early breast cancer patients admitted to the Oncology department at the University Hospital of Modena.
Who may be able to join
- Patients will be enrolled in the study if they meet all of the following inclusion criteria:
- Age ≥ 18 years
- Endocrine sensitivity defined as estrogen and or progesterone receptors expression as per local pathological standards
- Her 2 negativity determined as ASCO/CAP guidelines
- Patients receiving abemaciclib, olaparib and endocrine therapy, as per Italian drugs agency rules (AIFA)
- Written informed consent, signed and dated by the patients
Show all 21Show fewer
- High-risk HR positive, Her2 negative early breast cancer patients with one of the following characteristics:
- Anatomical stage IIA N0 with:
- Grade 2 and evidence of high risk:
- Ki-67 ≥ 20%
- Oncotype DX Breast Recurrence Score ≥ 26 or High risk via genomic risk profiling
- Grade 3
- Anatomical stage IIB.
- Pathological tumour involvement in ≥4 ipsilateral axillary lymph nodes.
- Pathological tumour involvement in 1 to 3 ipsilateral axillary lymph node(s) (for patients who received neoadjuvant therapy also cytological tumour involvement at time of initial diagnosis is allowed) and meet at least 1 of the following criteria:
- Grade 3 as defined by a combined score of at least 8 points per the modified Bloom-Richardson grading system (Elston and Ellis 1991),
- Pathological primary invasive tumour size ≥5 cm (for patients who received neoadjuvant therapy primary tumour size ≥5 cm on breast imaging is allowed). Note: if tumour size is needed to meet eligibility criteria, patients with multifocal/multicentric tumours may be eligible based on the addition of diameters of the individual lesions.
- BRCA mutated populations
- Patients must be node positive and fulfil one of the following criteria:
- HR positive, HER2-negative patients must have had ≥4 pathologically confirmed positive lymph nodes
- patients who received prior neoadjuvant chemotherapy: must have had a CPS\&EG score of ≥3 based on pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status and histologic grade
Who cannot join
- Patients unable to understand the reason for their participation in the study, lack of informed written consent,
- patients who do not meet the high risk criteria as specified in the inclusion criteria,
- patients suffering from other neoplasms for which they receive active treatment, or being diagnosed with other neoplasms (except for: Carcinoma in situ (CIS) of the cervix, CIS of the colon, basal cell and squamous cell carcinomas of the skin) in the five years before adjuvant treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, Modena, 41124
Luca Moscetti, MD, 0594223244 ext. 0039, moscetti.luca@aou.mo.it
Luca Moscetti, MD
About this study
The primary goal of this observational study is to describe the distribution of treatment options and patients' characteristics according to the definition of high-risk status in the early breast cancer (EBC) setting. Participants already taking intervention as part of their regular medical care for EBC will answer questionnaires to also assess quality of life and patient reported outcomes.
The recruitment phase will last about 2 years, each patient will be followed up for 5 years.
Read the detailed description
The treatment of high-risk hormone receptor (HR) positive, Her2 negative, early breast cancer (EBC) patients has recently changed following the results of practice changing phase III trials. The hormone therapy (HT) with tamoxifene (T) or Aromatase Inhibitors (AIs), in association with ovarian function failure suppression (OFS) in the premenopausal patients, represented the standard options available until 2022. The role of OFS, usually reached through the use of LhRh analogues in the premenopausal patients, was addressed and defined in the SOFT/TEXT trials. The association of LhRh analogues (LhRha) with exemestane (E) or T with LhRha in the premenopausal setting showed an improved disease free survival (DFS) if compared to T alone. Moreover, at 12 years of follow up, the E-LhRha increases the DFS if compared to T-LhRha3. In the SOFT study, premenopausal patients did not benefit from the addition of OFS, but for whose women at sufficient risk of recurrence to deserve adjuvant chemotherapy (CHT) and who maintained pre-menopausal estradiol, the addition of LhRha to T reduced the risk of recurrence. Moreover, the TEXT trial, adjuvant endocrine therapy with exemestane (E) plus LhRha, as compared with tamoxifen plus LhRha, significantly improved disease-free survival (DFS), breast cancer-free interval (BCFI) and distant disease-free survival (dDFS), thus representing a new treatment option for high-risk patients. The investigators of the SOFT and TEXT trials performed a combined secondary analysis to estimate the magnitude of absolute improvements in freedom from any recurrence (BCFI=breast cancer-free interval) according to quantitative composite measure of recurrence risk (hereafter referred to as "composite risk") defined by seven clinicopathologic characteristics.
Based on the results of MonarchE study, with the adjunct of Abemaciclib to the standard HT, the European Medicine Agency (EMA) recently approved Abemaciclib for the adjuvant treatment of high-risk EBC in combination with AI or T in the adjuvant setting. Moreover the results of OlympiA study highlights the role of Olaparib in the high-risk HR positive, Her2 negative, BRCA mutated, EBC patients. Based on the results of Olympia trial, Olaparib was approved for HR positive, HER2-negative patients who must have ≥4 pathologically confirmed positive lymph nodes or must have a CPS\&EG score of ≥3 based on pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status and histologic grade 8,9. Moreover Ribociclib recently has demonstrated activity in the phase III trial but a longer follow up will be needed to confirm the early results.
In this retrospective/prospective observational trial, we would like to assess the pattern of size in the high-risk HR positive, Her2 negative early breast cancer patients including BRCA mutated patients. Patients already taking intervention as part of their regular medical care for EBC must signed an informed consent in order to be recruited. After the patient has signed the informed consent for the participation in the study, data on the demographic and clinic-pathological characteristics obtained from the patients' computerized medical records will be collected and entered into an anonymized database. Questionnaires will also be administered to prospectively enrolled patients in order to evaluate quality of life and patient reported outcomes.
The recruitment phase will last about 2 years, each patient will be followed up for 5 years.
- Conditions
- Breast Cancer
- Being tested
- abemaciclib, olaparib and endocrine therapy
- Keywords
- Breast cancer, Adjuvant treatment, Safety, Quality of life, Patient reported outcome
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abemaciclib, olaparib and endocrine therapyDrug
Patients receiving abemaciclib, olaparib and endocrine therapy.
| Study group | Role | What they receive |
|---|---|---|
| ADJUVANT IN EBC | High-risk HR positive, Her2 negative early breast cancer patients receiving abemaciclib, olaparib and endocrine therapy. Receives: Drug: abemaciclib, olaparib and endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of treatment options
Type of adjuvant treatment chosen
Measured: From enrollment to the end of treatment at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start26 Aug 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Moscetti, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151911
- Sponsor's protocol ID
- 691/2023/OSS/AOUMO
- Acronym
- ROYAL
- Status last verified
- Aug 2025
- First submitted
- 12 Jul 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA; TEXT and SOFT Investigators; International Breast Cancer Study Group. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10;371(2):107-18. doi: 10.1056/NEJMoa1404037. Epub 2014 Jun 1.
PubMed 24881463Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Lang I, Gomez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE Jr, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT and TEXT Investigators and the International Breast Cancer Study Group. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med. 2018 Jul 12;379(2):122-137. doi: 10.1056/NEJMoa1803164. Epub 2018 Jun 4.
PubMed 29863451Pagani O, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Goetz MP, Ciruelos EM, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Chini C, Puglisi F, Spazzapan S, Ruhstaller T, Winer EP, Ruepp B, Loi S, Coates AS, Gelber RD, Goldhirsch A, Regan MM, Francis PA; SOFT and TEXT Investigators and the International Breast Cancer Study Group (a division of ETOP IBCSG Partners Foundation). Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. J Clin Oncol. 2023 Mar 1;41(7):1376-1382. doi: 10.1200/JCO.22.01064. Epub 2022 Dec 15.
PubMed 36521078Regan MM, Francis PA, Pagani O, Fleming GF, Walley BA, Viale G, Colleoni M, Lang I, Gomez HL, Tondini C, Pinotti G, Price KN, Coates AS, Goldhirsch A, Gelber RD. Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. J Clin Oncol. 2016 Jul 1;34(19):2221-31. doi: 10.1200/JCO.2015.64.3171. Epub 2016 Apr 4.
PubMed 27044936Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Martinez Rodriguez JL, Campone M, Hamilton E, Sohn J, Guarneri V, Okada M, Boyle F, Neven P, Cortes J, Huober J, Wardley A, Tolaney SM, Cicin I, Smith IC, Frenzel M, Headley D, Wei R, San Antonio B, Hulstijn M, Cox J, O'Shaughnessy J, Rastogi P; monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1;38(34):3987-3998. doi: 10.1200/JCO.20.02514. Epub 2020 Sep 20.
PubMed 32954927Harbeck N, Rastogi P, Martin M, Tolaney SM, Shao ZM, Fasching PA, Huang CS, Jaliffe GG, Tryakin A, Goetz MP, Rugo HS, Senkus E, Testa L, Andersson M, Tamura K, Del Mastro L, Steger GG, Kreipe H, Hegg R, Sohn J, Guarneri V, Cortes J, Hamilton E, Andre V, Wei R, Barriga S, Sherwood S, Forrester T, Munoz M, Shahir A, San Antonio B, Nabinger SC, Toi M, Johnston SRD, O'Shaughnessy J; monarchE Committee Members. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study. Ann Oncol. 2021 Dec;32(12):1571-1581. doi: 10.1016/j.annonc.2021.09.015. Epub 2021 Oct 14.
PubMed 34656740Geyer CE Jr, Garber JE, Gelber RD, Yothers G, Taboada M, Ross L, Rastogi P, Cui K, Arahmani A, Aktan G, Armstrong AC, Arnedos M, Balmana J, Bergh J, Bliss J, Delaloge S, Domchek SM, Eisen A, Elsafy F, Fein LE, Fielding A, Ford JM, Friedman S, Gelmon KA, Gianni L, Gnant M, Hollingsworth SJ, Im SA, Jager A, Johannsson OThorn, Lakhani SR, Janni W, Linderholm B, Liu TW, Loman N, Korde L, Loibl S, Lucas PC, Marme F, Martinez de Duenas E, McConnell R, Phillips KA, Piccart M, Rossi G, Schmutzler R, Senkus E, Shao Z, Sharma P, Singer CF, Spanic T, Stickeler E, Toi M, Traina TA, Viale G, Zoppoli G, Park YH, Yerushalmi R, Yang H, Pang D, Jung KH, Mailliez A, Fan Z, Tennevet I, Zhang J, Nagy T, Sonke GS, Sun Q, Parton M, Colleoni MA, Schmidt M, Brufsky AM, Razaq W, Kaufman B, Cameron D, Campbell C, Tutt ANJ; OlympiA Clinical Trial Steering Committee and Investigators. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022 Dec;33(12):1250-1268. doi: 10.1016/j.annonc.2022.09.159. Epub 2022 Oct 10.
PubMed 36228963Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
PubMed 31078660
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real wOrld studY in the Adjuvant Setting for High Risk earLy Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07151911
- Acronym / sponsor ID
- ROYAL / 691/2023/OSS/AOUMO
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Adjuvant treatment, Safety, Quality of life, Patient reported outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 3 Sep 2025 (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.
The primary goal of this observational study is to describe the distribution of treatment options and patients' characteristics according to the definition of high-risk status in the early breast cancer (EBC) setting. Participants already taking intervention as part of their regular medical care for EBC will answer questionnaires to also assess quality of life and patient reported outcomes.
The recruitment phase will last about 2 years, each patient will be followed up for 5 years.
Detailed description
The treatment of high-risk hormone receptor (HR) positive, Her2 negative, early breast cancer (EBC) patients has recently changed following the results of practice changing phase III trials. The hormone therapy (HT) with tamoxifene (T) or Aromatase Inhibitors (AIs), in association with ovarian function failure suppression (OFS) in the premenopausal patients, represented the standard options available until 2022. The role of OFS, usually reached through the use of LhRh analogues in the premenopausal patients, was addressed and defined in the SOFT/TEXT trials. The association of LhRh analogues (LhRha) with exemestane (E) or T with LhRha in the premenopausal setting showed an improved disease free survival (DFS) if compared to T alone. Moreover, at 12 years of follow up, the E-LhRha increases the DFS if compared to T-LhRha3. In the SOFT study, premenopausal patients did not benefit from the addition of OFS, but for whose women at sufficient risk of recurrence to deserve adjuvant chemotherapy (CHT) and who maintained pre-menopausal estradiol, the addition of LhRha to T reduced the risk of recurrence. Moreover, the TEXT trial, adjuvant endocrine therapy with exemestane (E) plus LhRha, as compared with tamoxifen plus LhRha, significantly improved disease-free survival (DFS), breast cancer-free interval (BCFI) and distant disease-free survival (dDFS), thus representing a new treatment option for high-risk patients. The investigators of the SOFT and TEXT trials performed a combined secondary analysis to estimate the magnitude of absolute improvements in freedom from any recurrence (BCFI=breast cancer-free interval) according to quantitative composite measure of recurrence risk (hereafter referred to as "composite risk") defined by seven clinicopathologic characteristics.
Based on the results of MonarchE study, with the adjunct of Abemaciclib to the standard HT, the European Medicine Agency (EMA) recently approved Abemaciclib for the adjuvant treatment of high-risk EBC in combination with AI or T in the adjuvant setting. Moreover the results of OlympiA study highlights the role of Olaparib in the high-risk HR positive, Her2 negative, BRCA mutated, EBC patients. Based on the results of Olympia trial, Olaparib was approved for HR positive, HER2-negative patients who must have ≥4 pathologically confirmed positive lymph nodes or must have a CPS\&EG score of ≥3 based on pre-treatment clinical and post-treatment pathologic stage (CPS), estrogen receptor (ER) status and histologic grade 8,9. Moreover Ribociclib recently has demonstrated activity in the phase III trial but a longer follow up will be needed to confirm the early results.
In this retrospective/prospective observational trial, we would like to assess the pattern of size in the high-risk HR positive, Her2 negative early breast cancer patients including BRCA mutated patients. Patients already taking intervention as part of their regular medical care for EBC must signed an informed consent in order to be recruited. After the patient has signed the informed consent for the participation in the study, data on the demographic and clinic-pathological characteristics obtained from the patients' computerized medical records will be collected and entered into an anonymized database. Questionnaires will also be administered to prospectively enrolled patients in order to evaluate quality of life and patient reported outcomes.
The recruitment phase will last about 2 years, each patient will be followed up for 5 years.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADJUVANT IN EBC | – | Drug: abemaciclib, olaparib and endocrine therapyHigh-risk HR positive, Her2 negative early breast cancer patients receiving abemaciclib, olaparib and endocrine therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High-risk HR positive, HER2 negative, early breast cancer patients admitted to the Oncology department at the University Hospital of Modena.
Key inclusion criteria (21 listed)
- Patients will be enrolled in the study if they meet all of the following inclusion criteria:
- Age ≥ 18 years
- Endocrine sensitivity defined as estrogen and or progesterone receptors expression as per local pathological standards
- Her 2 negativity determined as ASCO/CAP guidelines
- Patients receiving abemaciclib, olaparib and endocrine therapy, as per Italian drugs agency rules (AIFA)
Key exclusion criteria (3 listed)
- Patients unable to understand the reason for their participation in the study, lack of informed written consent,
- patients who do not meet the high risk criteria as specified in the inclusion criteria,
- patients suffering from other neoplasms for which they receive active treatment, or being diagnosed with other neoplasms (except for: Carcinoma in situ (CIS) of the cervix, CIS of the colon, basal cell and squamous cell carcinomas of the skin) in the five years before adjuvant treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abemaciclib, olaparib and endocrine therapyPatients receiving abemaciclib, olaparib and endocrine therapy. | Drug | ADJUVANT IN EBC |
Primary outcome
Distribution of treatment options
Time frame: From enrollment to the end of treatment at 5 years
Type of adjuvant treatment chosen
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 3 Sep 2025.
- Background: PubMed 24881463Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA; TEXT and SOFT Investigators; International Breast Cancer Study Group. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10;371(2):107-18. doi: 10.1056/NEJMoa1404037. Epub 2014 Jun 1.
- Background: PubMed 29863451Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Lang I, Gomez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE Jr, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT and TEXT Investigators and the International Breast Cancer Study Group. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med. 2018 Jul 12;379(2):122-137. doi: 10.1056/NEJMoa1803164. Epub 2018 Jun 4.
- Background: PubMed 36521078Pagani O, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Goetz MP, Ciruelos EM, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Chini C, Puglisi F, Spazzapan S, Ruhstaller T, Winer EP, Ruepp B, Loi S, Coates AS, Gelber RD, Goldhirsch A, Regan MM, Francis PA; SOFT and TEXT Investigators and the International Breast Cancer Study Group (a division of ETOP IBCSG Partners Foundation). Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. J Clin Oncol. 2023 Mar 1;41(7):1376-1382. doi: 10.1200/JCO.22.01064. Epub 2022 Dec 15.
- Background: PubMed 27044936Regan MM, Francis PA, Pagani O, Fleming GF, Walley BA, Viale G, Colleoni M, Lang I, Gomez HL, Tondini C, Pinotti G, Price KN, Coates AS, Goldhirsch A, Gelber RD. Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. J Clin Oncol. 2016 Jul 1;34(19):2221-31. doi: 10.1200/JCO.2015.64.3171. Epub 2016 Apr 4.
- Background: PubMed 32954927Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Martinez Rodriguez JL, Campone M, Hamilton E, Sohn J, Guarneri V, Okada M, Boyle F, Neven P, Cortes J, Huober J, Wardley A, Tolaney SM, Cicin I, Smith IC, Frenzel M, Headley D, Wei R, San Antonio B, Hulstijn M, Cox J, O'Shaughnessy J, Rastogi P; monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1;38(34):3987-3998. doi: 10.1200/JCO.20.02514. Epub 2020 Sep 20.
- Background: PubMed 34656740Harbeck N, Rastogi P, Martin M, Tolaney SM, Shao ZM, Fasching PA, Huang CS, Jaliffe GG, Tryakin A, Goetz MP, Rugo HS, Senkus E, Testa L, Andersson M, Tamura K, Del Mastro L, Steger GG, Kreipe H, Hegg R, Sohn J, Guarneri V, Cortes J, Hamilton E, Andre V, Wei R, Barriga S, Sherwood S, Forrester T, Munoz M, Shahir A, San Antonio B, Nabinger SC, Toi M, Johnston SRD, O'Shaughnessy J; monarchE Committee Members. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study. Ann Oncol. 2021 Dec;32(12):1571-1581. doi: 10.1016/j.annonc.2021.09.015. Epub 2021 Oct 14.
- Background: PubMed 36228963Geyer CE Jr, Garber JE, Gelber RD, Yothers G, Taboada M, Ross L, Rastogi P, Cui K, Arahmani A, Aktan G, Armstrong AC, Arnedos M, Balmana J, Bergh J, Bliss J, Delaloge S, Domchek SM, Eisen A, Elsafy F, Fein LE, Fielding A, Ford JM, Friedman S, Gelmon KA, Gianni L, Gnant M, Hollingsworth SJ, Im SA, Jager A, Johannsson OThorn, Lakhani SR, Janni W, Linderholm B, Liu TW, Loman N, Korde L, Loibl S, Lucas PC, Marme F, Martinez de Duenas E, McConnell R, Phillips KA, Piccart M, Rossi G, Schmutzler R, Senkus E, Shao Z, Sharma P, Singer CF, Spanic T, Stickeler E, Toi M, Traina TA, Viale G, Zoppoli G, Park YH, Yerushalmi R, Yang H, Pang D, Jung KH, Mailliez A, Fan Z, Tennevet I, Zhang J, Nagy T, Sonke GS, Sun Q, Parton M, Colleoni MA, Schmidt M, Brufsky AM, Razaq W, Kaufman B, Cameron D, Campbell C, Tutt ANJ; OlympiA Clinical Trial Steering Committee and Investigators. Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer. Ann Oncol. 2022 Dec;33(12):1250-1268. doi: 10.1016/j.annonc.2022.09.159. Epub 2022 Oct 10.
- Background: PubMed 18929686Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
- Background: PubMed 31078660Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Azienda Ospedaliero-Universitaria di Modena at 1 site 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 21 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. 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 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Luca Moscetti, MD (+ 39.059.422.3244, moscetti.luca@aou.mo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of treatment options (time frame: From enrollment to the end of treatment at 5 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 NCT07151911, which also lists 9 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 3 Sep 2025.