trialsTrialActive

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

A phase 2 trial of Abemaciclib and Tamoxifen in advanced solid tumours, run by Eli Lilly and Company, active and no longer recruiting.

Also called: Next MONARCH 1

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer is a phase 2 interventional study registered as NCT02747004 by Eli Lilly and Company, with 234 participants enrolled, started 2016-09-14 and due to reach its primary completion in 2018-06-15. Interventions recorded: Abemaciclib, Tamoxifen and Prophylactic Loperamide. Results have been posted on the registry.

Setting

A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer

Phase

Phase 2

Sponsor

Eli Lilly and Company

Registry

Started

2016-09-14

Reported

2019

Enrolled

234 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

234 enrolled

Progression Free Survival (PFS)primarysurrogate endpoint

Median 9.1 vs 6.5 months with 150mg Abemaciclib + 20mg Tamoxifen compared with 150mg Abemaciclib; about 2.6 months longer for half the group.
A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
Other groups: 200mg Abemaciclib + 2mg Prophylactic Loperamide 7.4 months.

This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.

Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)response endpoint

34.6 vs 24.1 out of 100 had their tumour shrink with 150mg Abemaciclib + 20mg Tamoxifen compared with 150mg Abemaciclib; 10.5 more per 100.
Roughly one extra person helped for every 10 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
Other groups: 200mg Abemaciclib + 2mg Prophylactic Loperamide 32.5 of 100.

A response rate counts how many people had their tumours shrink by a set amount; shrinking is encouraging but does not by itself show that people live longer or feel better.

Caveats

These results apply to the people the trial enrolled: A Randomized, Open-Label, Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone, in Women With Previously Treated Hormone Receptor-Positive, HER2-Negative, Metastatic Breast Cancer. People in a different situation may not see the same effect.
The trial selected people by a biomarker (HER2); the result should not be assumed for people whose cancer does not have it.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

234 enrolled.

Progression Free Survival (PFS)primary

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95% CI 6.90 to 10.95; Figures from the ClinicalTrials.gov results section (first posted 2019-07-12), not from a publication · 95% CI 4.77 to 9.21 · 95% CI 5.42 to 9.17

Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)

150mg Abemaciclib + 20mg Tamoxifen34.6 of 100

n = 78

150mg Abemaciclib24.1 of 100

n = 79

200mg Abemaciclib + 2mg Prophylactic Loperamide32.5 of 100

n = 77

Download

95% CI 24.1 to 45.2; Figures from the ClinicalTrials.gov results section (first posted 2019-07-12), not from a publication · 95% CI 14.6 to 33.5 · 95% CI 22 to 42.9

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Progression Free Survival (PFS)primary	150mg Abemaciclib + 20mg Tamoxifen	78	9.07 months	-	-	link
	150mg Abemaciclib	79	6.48 months
	200mg Abemaciclib + 2mg Prophylactic Loperamide	77	7.43 months
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)	150mg Abemaciclib + 20mg Tamoxifen	78	34.6%	-	-	link
	150mg Abemaciclib	79	24.1%
	200mg Abemaciclib + 2mg Prophylactic Loperamide	77	32.5%

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cancers

Metastatic cancer (cancer that has spread)

technologies

CDK4/6 inhibitors Endocrine therapy (SERMs, AIs, SERDs)

drugs

ApprovedSmall-molecule CDK4/6 inhibitor

Abemaciclib · Verzenio

ApprovedSmall-molecule SERM

Tamoxifen · Nolvadex

companies

Eli Lilly (incl. Loxo)