Trial Outcomes & Findings for Palbociclib and Binimetinib in Advanced Triple Negative Breast Cancer (NCT NCT04494958)

Last Updated: 2025-03-24

Results Overview

Progression free survival (PFS) is defined as the time from the date of start treatment until objective tumor progression or death from any reason. Patients who have not progressed or died at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST 1.1 assessment. Progression free survival at three months is provided.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

24 participants

Primary outcome timeframe

3 months

Results posted on

2025-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	Palbociclib + Binimetinib Combination, Palbociclib + Binimetinib: Patients will then start treatment with continuous oral binimetinib 45 mg/BID and palbociclib 100 mg daily, 21 days on / 7 days off, until disease progression. Study treatment will continue until disease progression. If treatment tolerance is good, after a full cycle patients will be allowed to escalate palbociclib to 125 mg, according to the study investigators' decision. Alternatively, patients with non tolerable grade 2 events will resume at 30 mg/BID of binimetinib upon recovery, maintaining palbociclib at 100 mg 21-on/7-off. Depending on the side-effects, in case of clear relationship with palbociclib is established, palbociclib -instead of binimetinib - will be reduced to 75 mg daily.
Overall Study STARTED	24
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Palbociclib and Binimetinib in Advanced Triple Negative Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Palbociclib + Binimetinib n=24 Participants Combination, Palbociclib + Binimetinib: Patients will then start treatment with continuous oral binimetinib 45 mg/BID and palbociclib 100 mg daily, 21 days on / 7 days off, until disease progression. Study treatment will continue until disease progression. If treatment tolerance is good, after a full cycle patients will be allowed to escalate palbociclib to 125 mg, according to the study investigators' decision. Alternatively, patients with non tolerable grade 2 events will resume at 30 mg/BID of binimetinib upon recovery, maintaining palbociclib at 100 mg 21-on/7-off. Depending on the side-effects, in case of clear relationship with palbociclib is established, palbociclib -instead of binimetinib - will be reduced to 75 mg daily.
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=99 Participants
Age, Categorical >=65 years	4 Participants n=99 Participants
Age, Continuous	53.8 years STANDARD_DEVIATION 12.6 • n=99 Participants
Sex: Female, Male Female	24 Participants n=99 Participants
Sex: Female, Male Male	0 Participants n=99 Participants
Race/Ethnicity, Customized Black	1 Participants n=99 Participants
Race/Ethnicity, Customized Latin	1 Participants n=99 Participants
Race/Ethnicity, Customized White	22 Participants n=99 Participants
Region of Enrollment Spain	24 participants n=99 Participants

PRIMARY outcome

Timeframe: 3 months

Population: All patients includeed in the study that received at least one dose of study treatment and have at least one evaluation visit after received the first dose of treatment.

Outcome measures

Outcome measures
Measure	Palbociclib + Binimetinib n=19 Participants Combination, Palbociclib + Binimetinib: Patients will then start treatment with continuous oral binimetinib 45 mg/BID and palbociclib 100 mg daily, 21 days on / 7 days off, until disease progression. Study treatment will continue until disease progression. If treatment tolerance is good, after a full cycle patients will be allowed to escalate palbociclib to 125 mg, according to the study investigators' decision. Alternatively, patients with non tolerable grade 2 events will resume at 30 mg/BID of binimetinib upon recovery, maintaining palbociclib at 100 mg 21-on/7-off. Depending on the side-effects, in case of clear relationship with palbociclib is established, palbociclib -instead of binimetinib - will be reduced to 75 mg daily.
3 Months Progression Free Survival. Probability That the Cancer Has Not Progressed at 3 Months Calculated With Kaplan Meier.	15.8 perceent probability at 3 months Interval 0.0 to 32.2

SECONDARY outcome

Timeframe: 3 months

Population: All patients included in this study that received at least one dose of study treatment and have at least one evaluation visit after received the first dose of treatment

Time from the date of first dose of study treatment to the date of progression or death (from any cause).

Outcome measures

Outcome measures
Measure	Palbociclib + Binimetinib n=19 Participants Combination, Palbociclib + Binimetinib: Patients will then start treatment with continuous oral binimetinib 45 mg/BID and palbociclib 100 mg daily, 21 days on / 7 days off, until disease progression. Study treatment will continue until disease progression. If treatment tolerance is good, after a full cycle patients will be allowed to escalate palbociclib to 125 mg, according to the study investigators' decision. Alternatively, patients with non tolerable grade 2 events will resume at 30 mg/BID of binimetinib upon recovery, maintaining palbociclib at 100 mg 21-on/7-off. Depending on the side-effects, in case of clear relationship with palbociclib is established, palbociclib -instead of binimetinib - will be reduced to 75 mg daily.
Progression Free Survival	1.8 Months Interval 1.6 to 2.1

SECONDARY outcome

Timeframe: 1 year

Population: All patients included in this study that received at least one dose of study treatment and have at least one evaluation visit after received the first dose of treatment

Percentage of patients that achieve complete response or partial response according to RECIST 1.1 criteria

Outcome measures

Outcome measures
Measure	Palbociclib + Binimetinib n=19 Participants Combination, Palbociclib + Binimetinib: Patients will then start treatment with continuous oral binimetinib 45 mg/BID and palbociclib 100 mg daily, 21 days on / 7 days off, until disease progression. Study treatment will continue until disease progression. If treatment tolerance is good, after a full cycle patients will be allowed to escalate palbociclib to 125 mg, according to the study investigators' decision. Alternatively, patients with non tolerable grade 2 events will resume at 30 mg/BID of binimetinib upon recovery, maintaining palbociclib at 100 mg 21-on/7-off. Depending on the side-effects, in case of clear relationship with palbociclib is established, palbociclib -instead of binimetinib - will be reduced to 75 mg daily.
Overall Response Rate	0 Participants

Adverse Events

Palbociclib + Binimetinib

Serious events: 4 serious events

Other events: 24 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Palbociclib + Binimetinib n=24 participants at risk Combination, Palbociclib + Binimetinib: Patients will then start treatment with continuous oral binimetinib 45 mg/BID and palbociclib 100 mg daily, 21 days on / 7 days off, until disease progression. Study treatment will continue until disease progression. If treatment tolerance is good, after a full cycle patients will be allowed to escalate palbociclib to 125 mg, according to the study investigators' decision. Alternatively, patients with non tolerable grade 2 events will resume at 30 mg/BID of binimetinib upon recovery, maintaining palbociclib at 100 mg 21-on/7-off. Depending on the side-effects, in case of clear relationship with palbociclib is established, palbociclib -instead of binimetinib - will be reduced to 75 mg daily.
Respiratory, thoracic and mediastinal disorders Pleural effusion	4.2% 1/24 • Number of events 1 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Nervous system disorders Radiculopathy	4.2% 1/24 • Number of events 1 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
General disorders Mucosal inflammation	4.2% 1/24 • Number of events 1 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Respiratory, thoracic and mediastinal disorders Immune-mediated lung disease	4.2% 1/24 • Number of events 1 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.

Other adverse events

Other adverse events
Measure	Palbociclib + Binimetinib n=24 participants at risk Combination, Palbociclib + Binimetinib: Patients will then start treatment with continuous oral binimetinib 45 mg/BID and palbociclib 100 mg daily, 21 days on / 7 days off, until disease progression. Study treatment will continue until disease progression. If treatment tolerance is good, after a full cycle patients will be allowed to escalate palbociclib to 125 mg, according to the study investigators' decision. Alternatively, patients with non tolerable grade 2 events will resume at 30 mg/BID of binimetinib upon recovery, maintaining palbociclib at 100 mg 21-on/7-off. Depending on the side-effects, in case of clear relationship with palbociclib is established, palbociclib -instead of binimetinib - will be reduced to 75 mg daily.
Blood and lymphatic system disorders Anaemia	37.5% 9/24 • Number of events 13 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Blood and lymphatic system disorders Neutropenia	50.0% 12/24 • Number of events 20 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Blood and lymphatic system disorders Thrombocytopenia	12.5% 3/24 • Number of events 5 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Eye disorders Blindness	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Eye disorders Ocular toxicity	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Eye disorders Retinopathy	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Eye disorders Scintillating scotoma	12.5% 3/24 • Number of events 6 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Eye disorders Vision blurred	16.7% 4/24 • Number of events 4 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Gastrointestinal disorders Abdominal pain	8.3% 2/24 • Number of events 5 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Gastrointestinal disorders Abdominal pain upper	16.7% 4/24 • Number of events 4 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Gastrointestinal disorders Constipation	20.8% 5/24 • Number of events 6 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Gastrointestinal disorders Diarrhoea	70.8% 17/24 • Number of events 28 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Gastrointestinal disorders Gingival bleeding	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Gastrointestinal disorders Nausea	16.7% 4/24 • Number of events 5 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Gastrointestinal disorders Stomatitis	8.3% 2/24 • Number of events 3 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Gastrointestinal disorders Vomiting	16.7% 4/24 • Number of events 4 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
General disorders Asthenia	70.8% 17/24 • Number of events 25 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
General disorders Chest pain	12.5% 3/24 • Number of events 3 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
General disorders Mucosal inflammation	16.7% 4/24 • Number of events 10 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
General disorders Oedema	12.5% 3/24 • Number of events 3 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
General disorders Oedema peripheral	16.7% 4/24 • Number of events 4 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
General disorders Pain	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
General disorders Pyrexia	29.2% 7/24 • Number of events 10 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Hepatobiliary disorders Hypertransaminasaemia	12.5% 3/24 • Number of events 3 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Infections and infestations COVID-19	12.5% 3/24 • Number of events 4 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Injury, poisoning and procedural complications Overdose	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Investigations Alanine aminotransferase increased	16.7% 4/24 • Number of events 4 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Investigations Aspartate aminotransferase increased	20.8% 5/24 • Number of events 6 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Investigations Blood creatine phosphokinase increased	20.8% 5/24 • Number of events 8 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Investigations Ejection fraction decreased	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Investigations Gamma-glutamyltransferase increased	8.3% 2/24 • Number of events 3 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Investigations Neutrophil count decreased	20.8% 5/24 • Number of events 6 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Investigations Platelet count decreased	25.0% 6/24 • Number of events 10 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Metabolism and nutrition disorders Hyperphosphataemia	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Metabolism and nutrition disorders Hypocalcaemia	8.3% 2/24 • Number of events 4 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Metabolism and nutrition disorders Hypophosphataemia	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Musculoskeletal and connective tissue disorders Arthralgia	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Musculoskeletal and connective tissue disorders Neck pain	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 4/24 • Number of events 4 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Nervous system disorders Dizziness	8.3% 2/24 • Number of events 4 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Nervous system disorders Headache	12.5% 3/24 • Number of events 3 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Reproductive system and breast disorders Breast pain	8.3% 2/24 • Number of events 2 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 3/24 • Number of events 3 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	29.2% 7/24 • Number of events 12 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Skin and subcutaneous tissue disorders Dermatitis acneiform	12.5% 3/24 • Number of events 4 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Skin and subcutaneous tissue disorders Rash	41.7% 10/24 • Number of events 22 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.
Vascular disorders Lymphoedema	16.7% 4/24 • Number of events 6 • All adverse events that occur during the period comprehended from the start of study treatment to 30 days after last dose of the investigational products were recorded, an average of 3 months.

Additional Information

Juan Luis Sanz

APICES

Phone: 91 816 68 04

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place