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PIK3CA-mutated HR+/HER2- LA/mBCPatient TypesHR+/HER2- mBCHR+/HER2+ LA/mBC< Back to homepageClinical Trial DataClinical Trial DataIBR + AI Efficacy & SafetyIBR + AI Additional AnalysesIBR + Fulvestrant Efficacy & SafetyIBR + Fulvestrant Additional AnalysesAdditional DataAdditional DataRCTs and RWESelect data and publicationsVideosPatient SupportPatient
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IBRANCE® (palbociclib) combinationtherapy for PIK3CA-mutated,endocrine-resistant HR+/HER2- LA/mBC1,2IBRANCE® (palbociclib) combination therapy for PIK3CA-mutated, endocrine-resistant HR+/HER2- LA/mBC1,2INAVO120 trial design
INAVO120 (NCT04191499) was a Phase 3, 1:1 randomized, double-blind, placebo-controlled trial assessing first-line IBRANCE + inavolisib + fulvestrant (n=161) vs IBRANCE + placebo + fulvestrant (n=164) in adult patients with PIK3CA-mutated HR+/HER2- LA or mBC who had relapsed during or within 12 months after the completion of adjuvant endocrine therapy (N=325).1-3
Patients were required to have an HbA1C <6% and fasting blood glucose <126 mg/dL. The study excluded patients with type 1 diabetes mellitus or type 2 diabetes mellitus requiring ongoing anti-hyperglycemic treatment at the start of study treatment.1,2
Key eligibility criteria1,2
Pre-, peri-, and postmenopausal women and men1,2*
PIK3CA-mutated, HR+/HER2- LA/mBC1,2†
Disease recurrence or progression during or within 12 months of adjuvant ET completion1-3
Fasting glucose <126 mg/dL and HbA1C <6%1,2
Measurable disease3‡
No prior therapy for aBC1,2
Patients with type 1 diabetes mellitus or type 2 diabetes mellitus requiring ongoing anti-hyperglycemic treatment at the start of study treatment were excluded1,2
ReferencesPre- and perimenopausal women and men received hormonal suppression via LHRH agonists for the duration of the trial treatment period.1,2PIK3CA-mutation positivity was determined by local testing of tumor tissue or ctDNA with an appropriately validated polymerase chain reaction or next-generation sequencing test performed at a Clinical Laboratory Improvement Amendments or equivalently certified laboratory, or by testing of ctDNA at a sponsor-designated central laboratory.1-3Per RECIST v1.1.3INAVO120 trial resultsPrimary endpointPIK3CA-mutated HR+/HER2- LA/mBC: IBRANCE + inavolisib + fulvestrant
In a Phase 3, 1:1 randomized, double-blind, placebo-controlled trial of adult patients with PIK3CA-mutated HR+/HER2- locally advanced or mBC with disease recurrence during or within 12 months of completing adjuvant endocrine therapy (N=325)1-3:
15-month mPFS with IBRANCE + inavolisib + fulvestrant1,2*†
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Investigator-assessed PFS results were supported by consistent results from a BICR assessment.1,2
ReferencesBICR=blinded independent central review; CI=confidence interval; FUL=fulvestrant; HER2-=human epidermal growth factor receptor 2-negative; HR=hazard ratio; HR+=hormone receptor-positive; IBR=IBRANCE; Inavo=inavolisib; LA=locally advanced; mBC=metastatic breast cancer; mPFS=median progression-free survival; PFS=progression-free survival; PIK3CA=phosphatidylinositol-3-kinase catalytic subunit alpha; PLB=placebo; RECIST=Response Evaluation Criteria in Solid Tumors.According to RECIST v1.1.1,2September 2023 data cutoff. Median follow-up was 21.3 months and 21.5 months in the inavolisib and placebo groups, respectively.3Secondary endpointsPIK3CA-mutated HR+/HER2- LA/mBC: IBRANCE + inavolisib + fulvestrantSelect secondary endpoints
In a Phase 3, 1:1 randomized, double-blind, placebo-controlled trial of adult patients with PIK3CA-mutated HR+/HER2- locally advanced or mBC with disease recurrence during or within 12 months of completing adjuvant endocrine therapy (N=325)1-3:
Overall survival (OS): At the time of the PFS analysis,* OS data were not mature with ~30% of deaths in the overall population1,2
Objective response rate (ORR): Objective response occurred in 58% of patients in the IBRANCE + inavolisib + fulvestrant arm (94/161 patients; 95% CI: 50-66) vs 25% in the placebo + IBRANCE + fulvestrant arm (41/164 patients; 95% CI: 19-32)1,2
Duration of response (DoR): Median DoR was 18.4 months with IBRANCE + inavolisib + fulvestrant (n=94; 95% CI: 10.4-22.2) vs 9.6 months with placebo + IBRANCE + fulvestrant (n=41; 95% CI: 7.4-16.6)1,2
The adverse reactions reported below occurred in ≥10% of patients, with ≥5% (all Grades) or ≥2% (Grade 3-4) higher incidence in the IBRANCE + inavolisib + fulvestrant arm in INAVO120.1,2
ReferencesHER2-=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; LA=locally advanced; mBC=metastatic breast cancer; PIK3CA=phosphatidylinositol-3-kinase catalytic subunit alpha.Includes aphthous ulcer, glossitis, glossodynia, lip ulceration, mouth ulceration, mucosal inflammation, and stomatitis.1,2No Grade 4 adverse reactions were observed.1,2Includes other related terms.1,2Includes dry skin, skin fissures, xerosis, and xeroderma.1,2Lab abnormalitiesPIK3CA-mutated HR+/HER2- LA/mBC: IBRANCE + inavolisib + fulvestrantLab abnormalities
The laboratory abnormalities reported below occurred in ≥10% of patients, with ≥2% higher incidence in the IBRANCE + inavolisib + fulvestrant arm in INAVO120.1,2
ReferencesALT=alanine aminotransferase; CTCAE=Common Terminology Criteria for Adverse Events; HER2-=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; LA=locally advanced; mBC=metastatic breast cancer; PIK3CA=phosphatidylinositol-3-kinase catalytic subunit alpha.The denominator used to calculate the rate varied from 122 to 160 based on the number of patients with a baseline value and at least one post-treatment value.1,2The denominator used to calculate the rate varied from 131 to 161 based on the number of patients with a baseline value and at least one post-treatment value.1,2No Grade 4 laboratory abnormalities were observed.1,2Grading according to CTCAE version 4.03.1,2Discontinuations and dose reductionsPIK3CA-mutated HR+/HER2- LA/mBC: IBRANCE + inavolisib + fulvestrantDiscontinuations and dose reductions due to adverse reactions in INAVO120
Adverse reactions leading to discontinuation of IBRANCE in patients receiving IBRANCE + inavolisib + fulvestrant were neutropenia, infections, alanine aminotransferase increased, gastric ulcer, intestinal perforation, hyperglycemia, type 2 diabetes mellitus, bone pain, musculoskeletal pain, transitional cell carcinoma, and acute kidney injury (0.6% each).1,2
Dose reductions of IBRANCE due to adverse reactions occurred in 38% of patients receiving IBRANCE + inavolisib + fulvestrant and in 30% of patients receiving IBRANCE + placebo + fulvestrant.1,2
Dose interruption of IBRANCE due to an adverse reaction occurred in 71% of patients receiving IBRANCE plus inavolisib and fulvestrant and in 61% of patients receiving IBRANCE plus placebo and fulvestrant. Adverse reactions leading to dose interruption of IBRANCE in ≥2% of patients receiving IBRANCE plus inavolisib and fulvestrant were neutropenia (56%), infections (29%), leukopenia (12%), stomatitis (4.9%), anemia (6%), thrombocytopenia (4.3%), diarrhea (3.7%), pyrexia (3.1%), alanine aminotransferase increased (2.5%), hyperglycemia (2.5%), and nausea (2.5%).
In INAVO120, permanent discontinuation of IBRANCE with an adverse reaction occurred in 4.9% of patients receiving IBRANCE plus inavolisib and fulvestrant. Neutropenia accounted for 0.6% of permanent discontinuations
Dose reduction of IBRANCE due to an adverse reaction occurred in 38% of patients receiving IBRANCE plus inavolisib and fulvestrant. Neutropenia accounted for 30% of dose reductions
Dose interruption of IBRANCE due to an adverse reaction occurred in 71% of patients receiving IBRANCE plus inavolisib and fulvestrant. Neutropenia accounted for 56% of dose interruptions
Inform patients to promptly report any fever
Monitor complete blood count (CBC) prior to starting IBRANCE, at the beginning of each new cycle, on Day 15 of the first 2 cycles, and as clinically indicated
Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia
Interstitial lung disease (ILD)/pneumonitis1,2
Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy
Cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported
Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (eg, hypoxia, cough, dyspnea)
In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient
Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis
Embryo-fetal toxicity1,2
Based on the mechanism of action, IBRANCE can cause fetal harm
Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose
IBRANCE may impair fertilityin males and has the potential to cause genotoxicity. Advise male patients to consider sperm preservation before taking IBRANCE. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose
Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants
CDK4/6=cyclin-dependent kinases 4 and 6; HER2-=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; LA=locally advanced; mBC=metastatic breast cancer; PIK3CA=phosphatidylinositol-3-kinase catalytic subunit alpha. aBC=advanced breast cancer; ctDNA=circulating tumor DNA; DoR=duration of response; ET=endocrine therapy; HbA1C=hemoglobin A1C; HER2-=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive; IM=intramuscular; LA=locally advanced; LHRH=luteinizing hormone-releasing hormone; mBC=metastatic breast cancer; ORR=objective response rate; OS=overall survival; PFS=progression-free survival; PIK3CA=phosphatidylinositol-3-kinase catalytic subunit alpha; PO=by mouth; QD=once daily; RECIST=Response Evaluation Criteria in Solid Tumors.References:IBRANCE capsules [prescribing information]. New York, NY. Pfizer Inc.; June 2026. IBRANCE tablets [prescribing information]. New York, NY. Pfizer Inc.; June 2026. Turner NC, Saura C, Juric D, et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med. 2024;391(17):1584-1596.
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INDICATIONSHER2-Negative Metastatic Breast Cancer
IBRANCE® (palbociclib) 125 mg capsules and tablets are indicated
For the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
an aromatase inhibitor as initial endocrine-based therapy; or
fulvestrant in patients with disease progression following endocrine therapy.
in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, following recurrence on or after completing adjuvant endocrine therapy.
HER2-Positive Metastatic Breast Cancer
IBRANCE® (palbociclib) 125 mg capsules and tablets are indicated in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.
IMPORTANT SAFETY INFORMATIONNeutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. In PATINA, neutropenia was the most frequently reported adverse reaction with an incidence of 78%, and Grade ≥3 neutropenia was reported in 61% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. Based on laboratory findings, 93% had a decrease in neutrophil counts including 47% with Grade 3 and 3.1% with Grade 4. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Febrile neutropenia has been reported in 0.8% of patients exposed to IBRANCE in the PATINA study. Inform patients to promptly report any fever. Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of first 2 cycles and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. In PATINA, 1% of IBRANCE-treated patients had ILD/pneumonitis of any grade and no Grade 3, 4, or fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g., hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis. Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients to consider sperm preservation before taking IBRANCE. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants. Serious adverse reactions occurred in 24% of patients in INAVO120 who received IBRANCE plus inavolisib and fulvestrant. Serious adverse reactions occurring in ≥1% of patients receiving IBRANCE plus inavolisib and fulvestrant included anemia (1.9%), diarrhea (1.2%), and urinary tract infection (1.2%). Fatal adverse reactions occurred in 3.7% of patients in INAVO120 who received IBRANCE plus inavolisib and fulvestrant, including (0.6% each) acute coronary syndrome, cerebral hemorrhage, cerebrovascular accident, COVID-19 infection, and gastrointestinal hemorrhage. The most (≥20%) common adverse reactions occurring in INAVO120, including laboratory abnormalities, for IBRANCE plus inavolisib and fulvestrant vs IBRANCE plus placebo and fulvestrant were decreased neutrophils (95% vs 97%), decreased hemoglobin (88% vs 85%), increased fasting glucose (85% vs 43%), decreased platelets (84% vs 71%), decreased lymphocytes (72% vs 68%), stomatitis (51% vs 27%), diarrhea (48% vs 16%), decreased calcium (42% vs 32%), fatigue (38% vs 25%), decreased potassium (38% vs 21%), increased creatinine (38% vs 30%), increased alanine aminotransferase (34% vs 29%), nausea (28% vs 17%), decreased sodium (28% vs 19%), decreased magnesium (27% vs 21%), rash (26% vs 19%), decreased appetite (24% vs 9%), COVID-19 infection (23% vs 10%), and headache (22% vs 14%). Other Clinical Trials Experience: venous thromboembolism has been reported as an adverse reaction following administration of IBRANCE. Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure. For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis. INDICATIONHER2-Negative Metastatic Breast CancerIBRANCE® (palbociclib) 125 mg capsules and tablets are indicated in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, following recurrence on or after completing adjuvant endocrine therapy.
