Trial Outcomes & Findings for Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer (NCT NCT02536742)

NCT ID: NCT02536742

Last Updated: 2024-02-26

Results Overview

Time from treatment initiation until documented disease progression according to RECIST 1.1 or death, whichever occurs first

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 124 participants
• Primary outcome timeframe: Maximum 36 months
• Results posted on: 2024-02-26

Participant Flow

Participant milestones

Measure	Experimental Palbociclib plus Fulvestrant Palbociclib: 125 mg, orally, daily for 3 weeks followed by 1 week off; repeated at every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment. Fulvestrant: 500mg, intramuscularly on days 1 and 15 of cycle 1, then on day 1 (+/- 3 days) of every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.
Overall Study STARTED	124
Overall Study COMPLETED	122
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Experimental Palbociclib plus Fulvestrant Palbociclib: 125 mg, orally, daily for 3 weeks followed by 1 week off; repeated at every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment. Fulvestrant: 500mg, intramuscularly on days 1 and 15 of cycle 1, then on day 1 (+/- 3 days) of every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.
Overall Study Did not start protocol therapy	1
Overall Study Patient determined to have triple-negative breast cancer, thus not having the target disease	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Experimental n=122 Participants Palbociclib plus Fulvestrant Palbociclib: 125 mg, orally, daily for 3 weeks followed by 1 week off; repeated at every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment. Fulvestrant: 500mg, intramuscularly on days 1 and 15 of cycle 1, then on day 1 (+/- 3 days) of every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.
Age, Customized <40 years	2 Participants n=122 Participants
Age, Customized 40-49 years	15 Participants n=122 Participants
Age, Customized 50-59 years	37 Participants n=122 Participants
Age, Customized 60-69 years	42 Participants n=122 Participants
Age, Customized 70-79 years	23 Participants n=122 Participants
Age, Customized 80+ years	3 Participants n=122 Participants
Sex: Female, Male Female	122 Participants n=122 Participants
Sex: Female, Male Male	0 Participants n=122 Participants
Region of Enrollment Belgium	73 participants n=122 Participants
Region of Enrollment Italy	46 participants n=122 Participants
Region of Enrollment United Kingdom	3 participants n=122 Participants

PRIMARY outcome

Timeframe: Maximum 36 months

Population: Patients who initiate treatment and have the target disease.

Time from treatment initiation until documented disease progression according to RECIST 1.1 or death, whichever occurs first

Outcome measures

Measure	Experimental n=122 Participants Palbociclib plus Fulvestrant Palbociclib: 125 mg, orally, daily for 3 weeks followed by 1 week off; repeated at every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment. Fulvestrant: 500mg, intramuscularly on days 1 and 15 of cycle 1, then on day 1 (+/- 3 days) of every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.
Number of Participants With and Without Progression Free Survival (PFS) Events PFS event, Yes	92 Participants
Number of Participants With and Without Progression Free Survival (PFS) Events PFS event, No	30 Participants

SECONDARY outcome

Timeframe: From date of enrolment until patient's end of treatment visit (or a maximum of 12 months after EoT in the absence of tumor progression), assessed up to 48 months.

Population: Patients who initiate treatment and have the target disease.

Best overall response is based on RECIST (Response evaluation criteria in solid tumors) 1.1 criteria and is defined as best response recorded from enrollment across all time points until disease progression. Confirmation of partial response (PR) or complete response (CR) by an additional scan was not requested in this trial (rationale: initially because of randomized placebo-controlled design; subsequently because no hypothesis testing of progression-free survival, PFS, distribution relative to an historical control).

Outcome measures

Measure	Experimental n=122 Participants Palbociclib plus Fulvestrant Palbociclib: 125 mg, orally, daily for 3 weeks followed by 1 week off; repeated at every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment. Fulvestrant: 500mg, intramuscularly on days 1 and 15 of cycle 1, then on day 1 (+/- 3 days) of every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.
Best Overall Response Complete response (CR)	6 Participants
Best Overall Response Partial response (PR)	20 Participants
Best Overall Response Stable disease (SD)	80 Participants
Best Overall Response Progressive disease (PD)	16 Participants

SECONDARY outcome

Timeframe: From date of enrolment until patient's end of treatment visit (or a maximum of 12 months after EoT in the absence of tumor progression), assessed up to 48 months.

Population: Patients who initiate treatment and have the target disease.

Disease control is defined as best overall response of complete response (CR) or partial response (PR), or stable disease (SD) (or non-CR/non-PD, progressive disease, in the case of non-measurable disease only) lasting for at least 24 weeks, measured from enrollment until first documentation of progressive disease

Outcome measures

Measure	Experimental n=122 Participants Palbociclib plus Fulvestrant Palbociclib: 125 mg, orally, daily for 3 weeks followed by 1 week off; repeated at every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment. Fulvestrant: 500mg, intramuscularly on days 1 and 15 of cycle 1, then on day 1 (+/- 3 days) of every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.
Best Overall Response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) Disease control not observed	33 Participants
Best Overall Response of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) Disease control observed (CR or PR or SD)	89 Participants

Adverse Events

Experimental

Serious events: 89 serious events

Other events: 0 other events

Deaths: 30 deaths

Serious adverse events

Measure	Experimental n=122 participants at risk Palbociclib plus Fulvestrant Palbociclib: 125 mg, orally, daily for 3 weeks followed by 1 week off; repeated at every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment. Fulvestrant: 500mg, intramuscularly on days 1 and 15 of cycle 1, then on day 1 (+/- 3 days) of every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.
Investigations Neutrophil count decrease	71.3% 87/122 • Maximum 36 months Adverse events (AEs) were collected using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. AEs were collected at the end of each cycle, from first dose of trial treatment until 28 days after all treatment discontinuation (collected at End of Treatment visit done within 30 days after stop of all trial treatment; or at the time of decision to stop the trial treatment if the decision is taken \>30 days after last dose).
Gastrointestinal disorders Anemia	1.6% 2/122 • Maximum 36 months Adverse events (AEs) were collected using Common Terminology Criteria for Adverse Events (CTCAE) v4.0. AEs were collected at the end of each cycle, from first dose of trial treatment until 28 days after all treatment discontinuation (collected at End of Treatment visit done within 30 days after stop of all trial treatment; or at the time of decision to stop the trial treatment if the decision is taken \>30 days after last dose).

Other adverse events

Adverse event data not reported

Additional Information

Head Trial Activities and Deputy Director: Dr. Heidi Roschitzki-Voser

International Breast Cancer Study Group

Phone: +41 31 511 94 00

Email: heidi.roschitzki@ibcsg.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place