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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCOOS-A1 | The patients in this array are treated with Abemaciclib and Letrozole/Anastrozole. |
| |
| BCOOS-A2 | The patients in this array are treated with Letrozole or Anastrozole. |
| |
| BCOOS-B1 | The patients in this array are treated with Abemaciclib and Fulvestrant. |
| |
| BCOOS-B2 | The patients in this array are treated with Fulvestrant only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abemaciclib and Letrozole/Anastrozole | Drug | Take the treatment with Abemaciclib and Letrozole/Anastrozole at the same time. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival(PFS) | The time from treatment initiation to either the first documented disease progression or death from any cause. | Through the completion of the study, for an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 36 months |
| Disease Control Rate(DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with histologically confirmed HR-positive breast cancer treated with abemaciclib in combination with endocrine therapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Cao, docter | Contact | +8653282911261 | caoyu@qdu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yu Cao, docter | The Affiliated Hospital of Qingdao University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center | Qingdao | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33149768 | Result | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000590451 | abemaciclib |
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| D000077267 | Fulvestrant |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Letrozole or Anastrozole | Drug | Take the treatment with Letrozole or Anastrozole. |
|
|
| Abemaciclib and Fulvestrant | Drug | Take the treatment with Abemaciclib and Fulvestrant at the same time. |
|
|
| Fulvestrant | Drug | Take the treatment with Fulvestrant only. |
|
|
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 |
| Up to 36 months |
| Toxicity rate | Adverse events from the time from treatment initiation to disease progression, patient death or last recorded | 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. | Up to 36 months |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |