Breast CancerNCT06341283
A Retrospective Real-world Study of Abemaciclib in HR+ Breast Cancer
An observational study of Breast Cancer and Neoplasms, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
The present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with hormone receptor-positive(HR+) breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Neoplasms, Breast Diseases
- What is being tested?
- Abemaciclib and Letrozole/Anastrozole, Letrozole or Anastrozole and Abemaciclib and Fulvestrant
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Jul 2025
- Phase
- Observational
- 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
Study population: Patients with histologically confirmed HR-positive breast cancer treated with abemaciclib in combination with endocrine therapy
Who may be able to join
- 18 years or older
- Histologically confirmed HR-positive breast cancer and Imaging/pathological evidence of metastasis is available
- Treatment with abemaciclib in combination with endocrine therapy
- Any endocrine therapy
- Having solid tumor efficacy evaluation criteria RECIST 1.1 measurable lesions
Who cannot join
- Combined with other primary malignancies
- Associated with serious non-tumor related diseases, such as cardiovascular system, respiratory system, nervous system, blood system, digestive system
- Pregnant or lactating women
- male breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Real-world Study of Efficacy, Safety, and Economic Assessment of Abemaciclib Tablets Based on Hospital Information System(HIS) in Hormone Recepter Positive(HR+) Breast Cancer Patients
The present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with hormone receptor-positive(HR+) breast cancer.
Read the detailed description
Based on clinical trials data, Abemaciclib has been approved for early and advanced breast cancer with HR+ and human epidermal growth factor 2 receptor-negative(HER2-), but clinical trials require real-world research data as supplementary validation supporting evidence. This study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with HR+ breast cancer. In addition, this trial will explore the efficacy of Abemaciclib in patients with HR+ and human epidermal growth factor 2 receptor-positive(Her2+) breast cancer.
This study will now include real-world data on efficacy, toxicity and economics of abemaciclib in the adjuvant setting in HR+ breast cancer. Participants to be enrolled will come from an online platform for researches which all the privacy information has been controlled. The investigators are going to gather 2 groups of breast-cancer-one-other-study(BCOOS) including BCOOS-A and BCOOS-B. Group BCOOS-A includes the patients treated with Abemaciclib and Letrozole/Anastrozole compared with treated with Letrozole/Anastrozole only. Group BCOOS-B includes the patients treated with Abemaciclib and Fulvestrant compared with treated with Fulvestrant only.
Investigators will measure clinical outcomes, adverse events and economics in each group above.
- Conditions
- Breast Cancer, Neoplasms, Breast Diseases
- Being tested
- Abemaciclib and Letrozole/Anastrozole, Letrozole or Anastrozole, Abemaciclib and Fulvestrant, Fulvestrant
- Keywords
- Abemaciclib, Real world study, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abemaciclib and Letrozole/AnastrozoleDrug
Also called BCOOS-A1
Take the treatment with Abemaciclib and Letrozole/Anastrozole at the same time.
Letrozole or AnastrozoleDrug
Also called BCOOS-A2
Take the treatment with Letrozole or Anastrozole.
Abemaciclib and FulvestrantDrug
Also called BCOOS-B1
Take the treatment with Abemaciclib and Fulvestrant at the same time.
FulvestrantDrug
Also called BCOOS-B2
Take the treatment with Fulvestrant only.
| Study group | Role | What they receive |
|---|---|---|
| BCOOS-A1 | The patients in this array are treated with Abemaciclib and Letrozole/Anastrozole. Receives: Drug: Abemaciclib and Letrozole/Anastrozole | |
| BCOOS-A2 | The patients in this array are treated with Letrozole or Anastrozole. Receives: Drug: Letrozole or Anastrozole | |
| BCOOS-B1 | The patients in this array are treated with Abemaciclib and Fulvestrant. Receives: Drug: Abemaciclib and Fulvestrant | |
| BCOOS-B2 | The patients in this array are treated with Fulvestrant only. Receives: Drug: Fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
The time from treatment initiation to either the first documented disease progression or death from any cause.
Measured: Through the completion of the study, for an average of 6 months
Secondary outcomes (4)
Objective Remission Rate(ORR)
The proportion of patients who achieved pre-defined tumor volume reduction and maintained the minimum time limit was the sum of complete response (CR) and partial response (PR) proportions.
Measured: Up to 36 months
Disease Control Rate(DCR)
The number of patients who achieved complete response(CR),partial response (PR) and stable lesion (SD) after treatment as a percentage of the evaluable cases
Measured: Up to 36 months
Toxicity rate
Adverse events from the time from treatment initiation to disease progression, patient death or last recorded
Measured: Up to 36 months
Cost-utility analysis(CUA)
In health economics the purpose of CUA is to estimate the ratio between the cost of a health-related intervention and the benefit it produces in terms of the number of years lived in full health by the beneficiaries.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Jul 2025 (estimated)
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 The Affiliated Hospital of Qingdao UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu Cao, docter, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341283
- Sponsor's protocol ID
- BCOOS2024
- Status last verified
- May 2024
- First submitted
- 26 Mar 2024
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhang QY, Sun T, Yin YM, Li HP, Yan M, Tong ZS, Oppermann CP, Liu YP, Costa R, Li M, Cheng Y, Ouyang QC, Chen X, Liao N, Wu XH, Wang XJ, Feng JF, Hegg R, Kanakasetty GB, Coccia-Portugal MA, Han RB, Lu Y, Chi HD, Jiang ZF, Hu XC. MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study. Ther Adv Med Oncol. 2020 Oct 22;12:1758835920963925. doi: 10.1177/1758835920963925. eCollection 2020.
PubMed 33149768
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Real-world Study of Efficacy, Safety, and Economic Assessment of Abemaciclib Tablets Based on Hospital Information System(HIS) in Hormone Recepter Positive(HR+) Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06341283
- Acronym / sponsor ID
- BCOOS2024
- Conditions
- Breast Cancer, Neoplasms, Breast Diseases
- Keywords
- Abemaciclib, Real world study, Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 2 Apr 2024 (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 present study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with hormone receptor-positive(HR+) breast cancer.
Detailed description
Based on clinical trials data, Abemaciclib has been approved for early and advanced breast cancer with HR+ and human epidermal growth factor 2 receptor-negative(HER2-), but clinical trials require real-world research data as supplementary validation supporting evidence. This study will assess real-world clinical outcomes, adverse events and economics from treatment with endocrine therapy(ET) combined with abemaciclib in patients with HR+ breast cancer. In addition, this trial will explore the efficacy of Abemaciclib in patients with HR+ and human epidermal growth factor 2 receptor-positive(Her2+) breast cancer.
This study will now include real-world data on efficacy, toxicity and economics of abemaciclib in the adjuvant setting in HR+ breast cancer. Participants to be enrolled will come from an online platform for researches which all the privacy information has been controlled. The investigators are going to gather 2 groups of breast-cancer-one-other-study(BCOOS) including BCOOS-A and BCOOS-B. Group BCOOS-A includes the patients treated with Abemaciclib and Letrozole/Anastrozole compared with treated with Letrozole/Anastrozole only. Group BCOOS-B includes the patients treated with Abemaciclib and Fulvestrant compared with treated with Fulvestrant only.
Investigators will measure clinical outcomes, adverse events and economics in each group above.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BCOOS-A1 | – | Drug: Abemaciclib and Letrozole/AnastrozoleThe patients in this array are treated with Abemaciclib and Letrozole/Anastrozole. |
| BCOOS-A2 | – | Drug: Letrozole or AnastrozoleThe patients in this array are treated with Letrozole or Anastrozole. |
| BCOOS-B1 | – | Drug: Abemaciclib and FulvestrantThe patients in this array are treated with Abemaciclib and Fulvestrant. |
| BCOOS-B2 | – | Drug: FulvestrantThe patients in this array are treated with Fulvestrant only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with histologically confirmed HR-positive breast cancer treated with abemaciclib in combination with endocrine therapy
Key inclusion criteria (5 listed)
- 18 years or older
- Histologically confirmed HR-positive breast cancer and Imaging/pathological evidence of metastasis is available
- Treatment with abemaciclib in combination with endocrine therapy
- Any endocrine therapy
- Having solid tumor efficacy evaluation criteria RECIST 1.1 measurable lesions
Key exclusion criteria (4 listed)
- Combined with other primary malignancies
- Associated with serious non-tumor related diseases, such as cardiovascular system, respiratory system, nervous system, blood system, digestive system
- Pregnant or lactating women
- male breast cancer
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 and Letrozole/AnastrozoleAlso: BCOOS-A1Take the treatment with Abemaciclib and Letrozole/Anastrozole at the same time. | Drug | BCOOS-A1 |
| Letrozole or AnastrozoleAlso: BCOOS-A2Take the treatment with Letrozole or Anastrozole. | Drug | BCOOS-A2 |
| Abemaciclib and FulvestrantAlso: BCOOS-B1Take the treatment with Abemaciclib and Fulvestrant at the same time. | Drug | BCOOS-B1 |
| FulvestrantAlso: BCOOS-B2Take the treatment with Fulvestrant only. | Drug | BCOOS-B2 |
Primary outcome
Progression-free survival(PFS)
Time frame: Through the completion of the study, for an average of 6 months
The time from treatment initiation to either the first documented disease progression or death from any cause.
4 secondary outcomes
Objective Remission Rate(ORR)
Time frame: Up to 36 months
Disease Control Rate(DCR)
Time frame: Up to 36 months
Toxicity rate
Time frame: Up to 36 months
Cost-utility analysis(CUA)
Time frame: Up to 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
- Results publication: PubMed 33149768Zhang QY, Sun T, Yin YM, Li HP, Yan M, Tong ZS, Oppermann CP, Liu YP, Costa R, Li M, Cheng Y, Ouyang QC, Chen X, Liao N, Wu XH, Wang XJ, Feng JF, Hegg R, Kanakasetty GB, Coccia-Portugal MA, Han RB, Lu Y, Chi HD, Jiang ZF, Hu XC. MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study. Ther Adv Med Oncol. 2020 Oct 22;12:1758835920963925. doi: 10.1177/1758835920963925. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Yu Cao, docter study director
The Affiliated Hospital of Qingdao University
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 and Neoplasms, run by The Affiliated Hospital of Qingdao University at 1 site in China.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 May 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Cao, docter (+8653282911261, caoyu@qdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: Through the completion of the study, for an average of 6 months). 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 NCT06341283, 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 10 May 2024.