Publication
US Food and Drug Administration Approval Summary: Inavolisib With Palbociclib and Fulvestrant for Endocrine-Resistant, PIK3CA-Mutated, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, Locally Advanced or Metastatic Breast Cancer.
Authors not recorded
- Source
- PubMed
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CIVIC-20260908-000001
Abstract
Abstract (excerpt)
Only the opening of the abstract is shown; abstract text may carry publisher copyright.
Data not yet available
Linked entities
Linked entities (67)
How each link was made (MeSH, dictionary, registry reference, curation…) and whether it has been validated. Candidate links are not counted in entity statistics.
Validated 67
- cancerMalignant Breast Neoplasmcivic_curation1.00
- drugFulvestrantcivic_curation1.00
- drugInavolisibcivic_curation1.00
- drugPalbociclibcivic_curation1.00
- genePIK3CAcivic_curation1.00
- variantPIK3CA C420Rcivic_curation1.00
- variantPIK3CA E453Acivic_curation1.00
- variantPIK3CA E453Dcivic_curation1.00
- variantPIK3CA E453Gcivic_curation1.00
- variantPIK3CA E453Kcivic_curation1.00
- variantPIK3CA E453Qcivic_curation1.00
- variantPIK3CA E453Vcivic_curation1.00
- variantPIK3CA E542Acivic_curation1.00
- variantPIK3CA E542Dcivic_curation1.00
- variantPIK3CA E542Gcivic_curation1.00
- variantPIK3CA E542Kcivic_curation1.00
- variantPIK3CA E542Qcivic_curation1.00
- variantPIK3CA E542Rcivic_curation1.00
- variantPIK3CA E542Vcivic_curation1.00
- variantPIK3CA E545Acivic_curation1.00
- variantPIK3CA E545Dcivic_curation1.00
- variantPIK3CA E545Gcivic_curation1.00
- variantPIK3CA E545Kcivic_curation1.00
- variantPIK3CA E545Lcivic_curation1.00
- variantPIK3CA E545Qcivic_curation1.00
- variantPIK3CA E545Rcivic_curation1.00
- variantPIK3CA E545Vcivic_curation1.00
- variantPIK3CA G1049Acivic_curation1.00
- variantPIK3CA G1049Ccivic_curation1.00
- variantPIK3CA G1049Dcivic_curation1.00
- variantPIK3CA G1049Rcivic_curation1.00
- variantPIK3CA G1049Scivic_curation1.00
- variantPIK3CA G106Acivic_curation1.00
- variantPIK3CA G106Dcivic_curation1.00
- variantPIK3CA G106Rcivic_curation1.00
- variantPIK3CA G106Scivic_curation1.00
- variantPIK3CA G106Vcivic_curation1.00
- variantPIK3CA G118Dcivic_curation1.00
- variantPIK3CA H1047Dcivic_curation1.00
- variantPIK3CA H1047Icivic_curation1.00
- variantPIK3CA H1047Lcivic_curation1.00
- variantPIK3CA H1047Ncivic_curation1.00
- variantPIK3CA H1047Pcivic_curation1.00
- variantPIK3CA H1047Qcivic_curation1.00
- variantPIK3CA H1047Rcivic_curation1.00
- variantPIK3CA H1047Tcivic_curation1.00
- variantPIK3CA H1047Ycivic_curation1.00
- variantPIK3CA K111Ecivic_curation1.00
- variantPIK3CA K111Ncivic_curation1.00
- variantPIK3CA K111Rcivic_curation1.00
- variantPIK3CA M1043Icivic_curation1.00
- variantPIK3CA M1043Tcivic_curation1.00
- variantPIK3CA M1043Vcivic_curation1.00
- variantPIK3CA N345Dcivic_curation1.00
- variantPIK3CA N345Hcivic_curation1.00
- variantPIK3CA N345Icivic_curation1.00
- variantPIK3CA N345Kcivic_curation1.00
- variantPIK3CA N345Scivic_curation1.00
- variantPIK3CA N345Tcivic_curation1.00
- variantPIK3CA N345Ycivic_curation1.00
- variantPIK3CA Q546Ecivic_curation1.00
- variantPIK3CA Q546Hcivic_curation1.00
- variantPIK3CA Q546Kcivic_curation1.00
- variantPIK3CA Q546Lcivic_curation1.00
- variantPIK3CA Q546Pcivic_curation1.00
- variantPIK3CA Q546Rcivic_curation1.00
- variantPIK3CA R88Qcivic_curation1.00
Curated evidence
Evidence citing this paper (8)
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 40845250
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| PIK3CA E453A + PIK3CA E453D + PIK3CA E453G + PIK3CA E453K + PIK3CA E453Q + PIK3CA E453V1 | ||||||||
| Fulvestrant + Inavolisib + PalbociclibCombination | Malignant Breast Neoplasm | Predictive | A | Supports Sensitivity Response | 3 | accepted | EID12540The phase III INAVO120 trial (NCT04191499) in 325 patients with endocrine-resistant, PIK3CA-mutated HR⁺/HER2⁻ locally advanced or metastatic breast cancer evaluated inavolisib plus palbociclib and ful… (full text at CIViC) PMID 40845250 · Wedam et al., 2025 · Open in CIViC | civic |
| PIK3CA E542A + PIK3CA E542D + PIK3CA E542G + PIK3CA E542K + PIK3CA E542Q + PIK3CA E542R + PIK3CA E542V1 | ||||||||
| Fulvestrant + Inavolisib + PalbociclibCombination | Malignant Breast Neoplasm | Predictive | A | Supports Sensitivity Response | 3 | accepted | EID12535The phase III INAVO120 trial (NCT04191499) in 325 patients with endocrine-resistant, PIK3CA-mutated HR⁺/HER2⁻ locally advanced or metastatic breast cancer evaluated inavolisib plus palbociclib and ful… (full text at CIViC) PMID 40845250 · Wedam et al., 2025 · Open in CIViC | civic |
| PIK3CA E545A + PIK3CA E545D + PIK3CA E545G + PIK3CA E545K + PIK3CA E545L + PIK3CA E545Q + PIK3CA E545R + PIK3CA E545V1 | ||||||||
| Fulvestrant + Inavolisib + PalbociclibCombination | Malignant Breast Neoplasm | Predictive | A | Supports Sensitivity Response | 3 | accepted | EID12534The phase III INAVO120 trial (NCT04191499) in 325 patients with endocrine-resistant, PIK3CA-mutated HR⁺/HER2⁻ locally advanced or metastatic breast cancer evaluated inavolisib plus palbociclib and ful… (full text at CIViC) PMID 40845250 · Wedam et al., 2025 · Open in CIViC | civic |
| PIK3CA G1049A + PIK3CA G1049C + PIK3CA G1049D + PIK3CA G1049R + PIK3CA G1049S + PIK3CA G106A + PIK3CA G106D + PIK3CA G106R + PIK3CA G106S + PIK3CA G106V + PIK3CA G118D1 | ||||||||
| Fulvestrant + Inavolisib + PalbociclibCombination | Malignant Breast Neoplasm | Predictive | A | Supports Sensitivity Response | 3 | accepted | EID12537The phase III INAVO120 trial (NCT04191499) in 325 patients with endocrine-resistant, PIK3CA-mutated HR⁺/HER2⁻ locally advanced or metastatic breast cancer evaluated inavolisib plus palbociclib and ful… (full text at CIViC) PMID 40845250 · Wedam et al., 2025 · Open in CIViC | civic |
| PIK3CA H1047D + PIK3CA H1047I + PIK3CA H1047L + PIK3CA H1047N + PIK3CA H1047P + PIK3CA H1047Q + PIK3CA H1047R + PIK3CA H1047T + PIK3CA H1047Y1 | ||||||||
| Fulvestrant + Inavolisib + PalbociclibCombination | Malignant Breast Neoplasm | Predictive | A | Supports Sensitivity Response | 3 | accepted | EID12533The phase III INAVO120 trial (NCT04191499) in 325 patients with endocrine-resistant, PIK3CA-mutated HR⁺/HER2⁻ locally advanced or metastatic breast cancer evaluated inavolisib plus palbociclib and ful… (full text at CIViC) PMID 40845250 · Wedam et al., 2025 · Open in CIViC | civic |
| PIK3CA N345D + PIK3CA N345H + PIK3CA N345I + PIK3CA N345K + PIK3CA N345S + PIK3CA N345T + PIK3CA N345Y1 | ||||||||
| Fulvestrant + Inavolisib + PalbociclibCombination | Malignant Breast Neoplasm | Predictive | A | Supports Sensitivity Response | 3 | accepted | EID12538The phase III INAVO120 trial (NCT04191499) in 325 patients with endocrine-resistant, PIK3CA-mutated HR⁺/HER2⁻ locally advanced or metastatic breast cancer evaluated inavolisib plus palbociclib and ful… (full text at CIViC) PMID 40845250 · Wedam et al., 2025 · Open in CIViC | civic |
| PIK3CA K111E + PIK3CA K111N + PIK3CA K111R + PIK3CA Q546E + PIK3CA Q546H + PIK3CA Q546K + PIK3CA Q546L + PIK3CA Q546P + PIK3CA Q546R1 | ||||||||
| Fulvestrant + Inavolisib + PalbociclibCombination | Malignant Breast Neoplasm | Predictive | A | Supports Sensitivity Response | 3 | accepted | EID12536The phase III INAVO120 trial (NCT04191499) in 325 patients with endocrine-resistant, PIK3CA-mutated HR⁺/HER2⁻ locally advanced or metastatic breast cancer evaluated inavolisib plus palbociclib and ful… (full text at CIViC) PMID 40845250 · Wedam et al., 2025 · Open in CIViC | civic |
| PIK3CA C420R + PIK3CA M1043I + PIK3CA M1043T + PIK3CA M1043V + PIK3CA R88Q1 | ||||||||
| Fulvestrant + Inavolisib + PalbociclibCombination | Malignant Breast Neoplasm | Predictive | A | Supports Sensitivity Response | 3 | accepted | EID12539The phase III INAVO120 trial (NCT04191499) in 325 patients with endocrine-resistant, PIK3CA-mutated HR⁺/HER2⁻ locally advanced or metastatic breast cancer evaluated inavolisib plus palbociclib and ful… (full text at CIViC) PMID 40845250 · Wedam et al., 2025 · Open in CIViC | civic |