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Metastatic Breast CancerPhase 2FAIMNCT04920708

Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression

A Phase 2 study testing Ipatasertib 300mg, Fulvestrant 500g and Palbociclib 75mg-125mg in people with Metastatic Breast Cancer and ER+ Breast Cancer, run by Royal Marsden NHS Foundation Trust at 13 sites in United Kingdom.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Analysis of circulating tumour DNA (ctDNA) found in a patient's peripheral blood can identify cancer progression and predict a patient's response to therapy. By using ctDNA analysis and imaging techniques, the FAIM trial aims to determine whether the addition of the experimental drug ipatasertib to a standard… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ipatasertib 300mg, Fulvestrant 500g and Palbociclib 75mg-125mg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
13 sitesUnited Kingdom
Study dates
28 Dec 2022to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological diagnosis of metastatic or inoperable locally advanced ER positive/HER2 negative breast cancer. Assessment of ER and HER2 status as per local assessment. Histologically proven primary ER+ (Allred score 3/8 or greater, or stain in more than 1% of cancer cells) and HER2- (immunohistochemistry 0/1+ or negative by in situ hybridization) breast cancer as determined by local laboratory.
  • Willingness to consent for an archival tumour tissue sample (of advanced disease) to be requested for transfer to the Royal Marsden during study screening for future analysis. Patients without a metastatic biopsy are eligible if archival tumour from the breast primary tumour is available, but only after discussion with the Chief Investigator (see section 7.3.1). (PI assessment that a biopsy is not clinically appropriate will be required as evidence before discussion with the CI).
  • Previously treated with no more than one prior line of chemotherapy for advanced disease.
  • Patients eligible according to standard of care for fulvestrant in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib).
  • Patients must have progressed on or within 1 month from stopping prior endocrine therapy for advanced disease, or relapsed on or within 12 months of completing adjuvant endocrine therapy.
  • Measurable disease according to RECIST 1.1 or assessable bone disease (lytic or mixed lytic/sclerotic).
Show all 21Show fewer
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Adequate bone marrow, renal, and liver function within 14 days prior to the first study treatment on Day 1 of Cycle 1, defined as:
  • Neutrophils (ANC >= 2000/uL), haemoglobin >= 90 g/L, platelet count >= 100 x 10^9/L
  • Serum albumin >= 3 g/dL
  • Total bilirubin <= 1.5 times the upper limit of normal (ULN). Patients with known Gilbert syndrome may be enrolled if bilirubin <= 3 times ULN
  • AST and ALT <= 2.5 times ULN. Patients with documented liver or bone metastases may have AST and ALT <= 5 times ULN
  • ALP <= 2 times ULN. Patients with known liver involvement may have ALP <= 5 times ULN. Patients with known bone involvement may have ALP <= 7 times ULN
  • Serum creatinine <= 1.5 times ULN or creatinine clearance >= 50 mL/min using the Cockcroft-Gault formula
  • INR < 1.5 times ULN and aPTT < 1.5 times ULN. Patients requiring anticoagulation should receive low-molecular-weight heparin or a direct oral anticoagulant
  • Fasting glucose <= 150 mg/dL and HbA1c <= 7.5%.
  • Negative serum pregnancy test at screening for females of childbearing potential.
  • Patients able to have children must agree to use a highly effective method of contraception (failure rate less than 1% per year) throughout the study and for at least two years after the last dose of fulvestrant and 90 days after the last dose of palbociclib or ipatasertib. Patients must also agree to refrain from donating eggs or sperm during this period.
  • Pre- or peri-menopausal patients must be treated with licensed GnRH analogues as per standard of care.
  • Aged 18 years or older.
  • Written informed consent has been provided, signed and dated.

Who cannot join

  • Prior exposure to adjuvant CDK4/6 inhibitors (abemaciclib, palbociclib, or ribociclib) for early breast cancer less than 12 months (52 weeks or 365 days) prior to breast cancer recurrence.
  • Prior treatment with fulvestrant for advanced breast cancer.
  • Prior treatment with an AKT inhibitor, PIK3CA inhibitor, or mTOR inhibitor in any setting.
  • History of malabsorption syndrome or other condition that would interfere with enteral absorption, or inability or unwillingness to swallow oral medication.
  • Systemic chemotherapy within 14 days or endocrine therapy within 7 days prior to registration.
  • Major surgery within 4 weeks prior to registration.
Show all 35Show fewer
  • Palliative radiotherapy within 14 days prior to registration.
  • Known leptomeningeal disease, untreated brain metastases, spinal cord compression, or symptomatic brain metastases requiring steroids.
  • Clinically significant, uncontrolled cardiac disease or cardiac repolarization abnormality, including but not limited to:
  • Angina pectoris, symptomatic pericarditis, coronary artery bypass graft, or myocardial infarction within 12 months prior to study entry
  • Symptomatic cardiac failure (NYHA class II to IV or LVEF < 50%), uncontrolled hypertension, cardiac dysrhythmia requiring medication, significant or symptomatic bradycardia, long QT syndrome, family history of congenital long QT syndrome or idiopathic sudden death
  • Cerebrovascular accident or transient ischemic attack within 12 months
  • Known risk factors for prolonged QT interval or Torsade de Pointes
  • Uncorrected hypomagnesaemia or hypokalaemia of Grade 3 or higher
  • Systolic blood pressure > 160 mmHg or < 90 mmHg
  • Resting heart rate < 50 beats per minute
  • Screening QTcF > 470 ms based on the mean of three ECGs
  • Lung disease including any history of pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, aspergillosis, active tuberculosis, or opportunistic infections such as pneumocystis pneumonia or cytomegalovirus pneumonia.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites as judged by the investigator.
  • Type I or II diabetes requiring insulin therapy.
  • Use of potent CYP3A4 inducers or inhibitors within 2 weeks or five elimination half-lives (whichever is longer) prior to the first dose of palbociclib with or without ipatasertib.
  • Known HIV infection or AIDS-related illness.
  • Active infection requiring systemic therapy.
  • Known acute or chronic hepatitis B or C infection.
  • Patients with resolved hepatitis B infection (HBsAg negative, HBcAb positive, and HBV DNA negative) are eligible
  • Patients positive for HCV antibody are eligible only if HCV RNA by PCR is negative
  • Clinically significant liver disease consistent with Child-Pugh class B or C.
  • Administration of a live vaccine within 4 weeks prior to study entry.
  • Diagnosis of another malignancy within 5 years, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the breast or cervix.
  • Participation in another study involving investigational drugs within 4 weeks prior to study entry or during study participation.
  • Persisting toxicity related to prior therapy greater than Grade 1, except stable peripheral neuropathy Grade 2 or alopecia Grade 2.
  • Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or interfere with interpretation of results, including colitis, inflammatory bowel disease, active bowel inflammation (for example diverticulitis), psychiatric illness, recent or active suicidal ideation or behaviour, or end-stage renal disease requiring haemodialysis.
  • Known allergy or hypersensitivity to ipatasertib, palbociclib, fulvestrant, or any of their components.
  • Pregnancy or breastfeeding.
  • Requirement for chronic corticosteroid therapy greater than 10 mg prednisolone per day, or equivalent doses of other systemic corticosteroids or immunosuppressants for chronic disease.

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United Kingdom13 sites

  • Addenbrookes Hospital

    Cambridge, Cambridgeshire, CB2 0QQ

  • Velindre Cancer Centre

    Cardiff, Wales, CF14 2TL

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Beatson West of Scotland Cancer Centre

    Glasgow

  • Mount Vernon Cancer Centre

    London, Surrey, HA6 2RN

  • Royal Free Hospital

    London, NW3 2QC

  • Royal Marsden NHS Foundation Trust

    London, SW3 6JJ

  • Imperial College University Hospitals NHS Trust

    London, W2 1NY

  • University College London Hospital

    London

  • The Christie NHS Foundation Trust

    Manchester, M20 4BX

  • Nottingham City Hospital

    Nottingham

  • Oxford University Hospitals

    Oxford, OX3 7LE

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LQ

Other trials in United Kingdom

About this study

Official title: Randomised Open-label Phase II Study of Induction Standard of Care Fulvestrant and CDK4/6 Inhibition With the Addition of Ipatasertib in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression

Analysis of circulating tumour DNA (ctDNA) found in a patient's peripheral blood can identify cancer progression and predict a patient's response to therapy. By using ctDNA analysis and imaging techniques, the FAIM trial aims to determine whether the addition of the experimental drug ipatasertib to a standard combination of the hormone treatment fulvestrant and the targeted agent palbociclib increases progression free survival (PFS) for patients with hormone-receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer.

Read the detailed description

Circulating tumour DNA (ctDNA) can be found in the peripheral blood of patients with cancer. ctDNA analysis provides a readily available, serial source of tumour DNA which can be used to monitor disease and predict a patients response to therapy.

Relative changes in ctDNA after 15 days of treatment with palbociclib and fulvestrant has been found to strongly predict progression free survival (PFS) in hormone-receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-) breast cancer patients: patients without ctDNA suppression after 2 weeks of treatment had a significantly shorter PFS compared to those with ctDNA suppression, identifying a group of patients who require additional therapy to prevent early progression.

The FAIM trial is a randomised, open-label study which will aim to determine whether the addition of ipatasertib to standard of care CDK4/6 inhibitors + fulvestrant increases PFS in patients who lack ctDNA suppression after 15 days of treatment. Patients starting standard of care CDK4/6 inhibitors + fulvestrant will have a ctDNA assessment on cycle 1 day 1 (C1D1) and cycle 1 day 15 (C1D15). Those with high ctDNA levels at C1D15 will be randomised on a 1:1 basis to either standard of care (CDK4/6 inhibitors + fulvestrant) or standard of care plus the experimental drug ipatasertib (CDK4/6 inhibitor + fulvestrant + ipatasertib). Patients with ctDNA suppression at C1D15 will continue standard of care (fulvestrant+CDK4/6 inhibitor); the first 100 patients of this group will be followed for PFS and ctDNA collection. Patients without detectable ctDNA on C1D1 will be followed and treated according standard of care; the first 50 patients of this group will be followed for PFS, overall survival (OS), time to next treatment, and time to chemotherapy. Progression free survival will be monitored using RECIST 1.1.

Being tested
Ipatasertib 300mg, Fulvestrant 500g, Palbociclib 75mg-125mg, CDK4/6 Inhibitor
Keywords
Fulvestrant, Palbociclib, Ipatasertib, ctDNA
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ipatasertib 300mgDrug

    Also called RG7440

    Ipatasertib 300mg once daily. Oral administration. Treatment is continuous daily for 21 days, followed by 7 days off, to complete a 28 day cycle.

  • Fulvestrant 500gDrug

    Also called Faslodex

    Fulvestrant 500mg administered intramuscularly in the buttocks slowly (1-2 minutes per injection) as two 5-mL injections (one in each buttock). Administered days 1 and 15 of Cycle 1. For subsequent cycles, patients will receive fulvestrant as described above in the clinic on Day 1 of each cycle or approximately every 4 weeks.

  • Palbociclib 75mg-125mgDrug

    Also called Ibrance

    Palboclicib 75mg-125mg once daily, dependent on toxicities. Oral administration. Treatment is continuous daily for 21 days, followed by 7 days off, to complete a 28 day cycle.

  • CDK4/6 InhibitorDrug

    Also called Abemaciclib / Ribociclib / Palbociclib

    CDK4/6 inhibitor. As per current standard of care regime for ER+/HER2- breast cancer.

Study groups in NCT04920708
Study groupRoleWhat they receive
Palbociclib + Fulvestrant + Ipatasertib (Interventional arm)ExperimentalWhere high ctDNA is detected in screening, patients to be randomised on a 1:1 basis to interventional arm or comparison arm. Patients randomised to interventional arm receive Palbociclib + Fulvestrant + Ipatasertib. n = 87.
Receives: Drug: Ipatasertib 300mg; Drug: Fulvestrant 500g; Drug: Palbociclib 75mg-125mg
Palbociclib + Fulvestrant (Comparison arm)Active comparatorWhere high ctDNA is detected in screening, patients to be randomised on a 1:1 basis to interventional arm or comparison arm. Patients randomised to Comparison arm receive Palbociclib + Fulvestrant. n = 87.
Receives: Drug: Fulvestrant 500g; Drug: Palbociclib 75mg-125mg
Standard of Care (No ctDNA observational arm)Active comparatorWhere no ctDNA is detected in screening, patients to be allocated to the observational arm and receive standard of care (Abemaciclib / Ribociclib / Palbociclib + fulvestrant). n = 50.
Receives: Drug: Fulvestrant 500g; Drug: CDK4/6 Inhibitor
Standard of Care (Low ctDNA observational arm)Active comparatorWhere low ctDNA is detected in screening, patients to be allocated to the observational arm and receive standard of care (Abemaciclib / Ribociclib / Palbociclib + fulvestrant). n = 100.
Receives: Drug: Fulvestrant 500g; Drug: CDK4/6 Inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess progression free survival (PFS)

    To compare PFS in patients randomised between SOC palbociclib/fulvestrant + ipatasertib and SOC CDK4/6 inhibitor/fulvestrant alone, in advanced ER+/HER2- breast cancer patients with trackable mutations and high ctDNA after 2 weeks of CDK4/6 inhibitor/fulvestrant.

    Measured: Time from date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 51 months

Secondary outcomes (5)

  1. To assess the AEs/SAEs for patients on palbociclib/fulvestrant/ipatasertib compared to palbociclib/fulvestrant alone

    To assess the overall safety and tolerability of standard of care palbociclib/fulvestrant + ipatasertib compared to standard of care CDK4/6 inhibitor/fulvestrant alone. Safety will be evaluated continuously by monitoring adverse events and serious adverse events, graded according to NCI CTCAE Version 5.0. SAEs will be collected from registration until 30 days post last trial treatment administration. AEs will be collected from Cycle 2 day 1 until 30 days post last trial treatment administration.

    Measured: 51 months (treatment duration + follow-up duration)

  2. Assess overall survival

    • To assess Overall Survival (OS) in patients receiving standard of care palbociclib/fulvestrant + ipatasertib compared to SOC CDK4/6 inhibitor/fulvestrant alone.

    Measured: 51 months (treatment duration + follow-up duration)

  3. Assess objective response rate

    • To assess the objective response rate in patients receiving SOC palbociclib/fulvestrant + ipatasertib compared to SOC CDK4/6 inhibitor/fulvestrant alone.

    Measured: 51 months (treatment duration + follow-up duration)

  4. Report progression free survival (PFS) in patients with low ctDNA and high ctDNA

    • To report progression free survival (PFS) in patients with suppressed ctDNA on standard of care CDK4/6 inhibitor/fulvestrant within the observational arm.

    Measured: Time from date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 51 months

  5. Compare progression free survival (PFS) in the subgroup of advanced ER+/HER2- breast cancer patients

    To report PFS in patients randomised between standard of care palbociclib/fulvestrant + ipatasertib and standard of care CDK4/6 inhibitor/fulvestrant alone, in the subgroup of advanced ER+/HER2- breast cancer patients with PIK3CA/PTEN/AKT1 mutations or PTEN loss.

    Measured: Time from date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 51 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2021
  2. Study start28 Dec 2022
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients starting standard of care CDK4/6 inhibitors and fulvestrant will have ctDNA assessment at Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15). Patients with high ctDNA levels at C1D1 and D15 will be randomised in a 1:1 ratio to CDK4/6 inhibitor + fulvestrant (comparison arm) or palbociclib + fulvestrant + ipatasertib (interventional arm). Patients with ctDNA suppressed at C1D15 will continue standard of care, fulvestrant+CDK4/6 inhibitor (observational arm). The first 100 patients of this group will be followed for PFS, OS and ctDNA collection. Patients with no detectable ctDNA at screening will continue on standard of care. The first 50 of this group will be followed for PFS, OS, time to next treatment, and time to chemotherapy.
Masking
None (open label)
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04920708
Sponsor's protocol ID
CCR5214
Acronym
FAIM
Status last verified
Apr 2026
First submitted
27 May 2021
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The confidentiality of patients participating in this trial will be protected and each participant will be assigned a unique trial number at the point of registration which will be used to identify eCRFs and anything else sent to the sponsor or other third parties. No patient identifiable data will be shared outside of the participating site.

Publications

  • Turner NC, Ro J, Andre F, Loi S, Verma S, Iwata H, Harbeck N, Loibl S, Huang Bartlett C, Zhang K, Giorgetti C, Randolph S, Koehler M, Cristofanilli M; PALOMA3 Study Group. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2015 Jul 16;373(3):209-19. doi: 10.1056/NEJMoa1505270. Epub 2015 Jun 1.

    PubMed 26030518

  • Turner NC, Slamon DJ, Ro J, Bondarenko I, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Loibl S, Andre F, Puyana Theall K, Huang X, Giorgetti C, Huang Bartlett C, Cristofanilli M. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2018 Nov 15;379(20):1926-1936. doi: 10.1056/NEJMoa1810527. Epub 2018 Oct 20.

    PubMed 30345905

  • Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3.

    PubMed 26947331

  • O'Leary B, Hrebien S, Morden JP, Beaney M, Fribbens C, Huang X, Liu Y, Bartlett CH, Koehler M, Cristofanilli M, Garcia-Murillas I, Bliss JM, Turner NC. Early circulating tumor DNA dynamics and clonal selection with palbociclib and fulvestrant for breast cancer. Nat Commun. 2018 Mar 1;9(1):896. doi: 10.1038/s41467-018-03215-x.

    PubMed 29497091

  • Bettegowda C, Sausen M, Leary RJ, Kinde I, Wang Y, Agrawal N, Bartlett BR, Wang H, Luber B, Alani RM, Antonarakis ES, Azad NS, Bardelli A, Brem H, Cameron JL, Lee CC, Fecher LA, Gallia GL, Gibbs P, Le D, Giuntoli RL, Goggins M, Hogarty MD, Holdhoff M, Hong SM, Jiao Y, Juhl HH, Kim JJ, Siravegna G, Laheru DA, Lauricella C, Lim M, Lipson EJ, Marie SK, Netto GJ, Oliner KS, Olivi A, Olsson L, Riggins GJ, Sartore-Bianchi A, Schmidt K, Shih lM, Oba-Shinjo SM, Siena S, Theodorescu D, Tie J, Harkins TT, Veronese S, Wang TL, Weingart JD, Wolfgang CL, Wood LD, Xing D, Hruban RH, Wu J, Allen PJ, Schmidt CM, Choti MA, Velculescu VE, Kinzler KW, Vogelstein B, Papadopoulos N, Diaz LA Jr. Detection of circulating tumor DNA in early- and late-stage human malignancies. Sci Transl Med. 2014 Feb 19;6(224):224ra24. doi: 10.1126/scitranslmed.3007094.

    PubMed 24553385

  • Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J, Rosso S, Coebergh JW, Comber H, Forman D, Bray F. Cancer incidence and mortality patterns in Europe: estimates for 40 countries in 2012. Eur J Cancer. 2013 Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027. Epub 2013 Feb 26.

    PubMed 23485231

  • Telli ML, Gradishar WJ, Ward JH. NCCN Guidelines Updates: Breast Cancer. J Natl Compr Canc Netw. 2019 May 1;17(5.5):552-555. doi: 10.6004/jnccn.2019.5006.

    PubMed 31117035

  • Cardoso F, Senkus E, Costa A, Papadopoulos E, Aapro M, Andre F, Harbeck N, Aguilar Lopez B, Barrios CH, Bergh J, Biganzoli L, Boers-Doets CB, Cardoso MJ, Carey LA, Cortes J, Curigliano G, Dieras V, El Saghir NS, Eniu A, Fallowfield L, Francis PA, Gelmon K, Johnston SRD, Kaufman B, Koppikar S, Krop IE, Mayer M, Nakigudde G, Offersen BV, Ohno S, Pagani O, Paluch-Shimon S, Penault-Llorca F, Prat A, Rugo HS, Sledge GW, Spence D, Thomssen C, Vorobiof DA, Xu B, Norton L, Winer EP. 4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4)dagger. Ann Oncol. 2018 Aug 1;29(8):1634-1657. doi: 10.1093/annonc/mdy192. No abstract available.

    PubMed 30032243

  • Johnston SR. Enhancing the efficacy of hormonal agents with selected targeted agents. Clin Breast Cancer. 2009 Jun;9 Suppl 1:S28-36. doi: 10.3816/CBC.2009.s.003.

    PubMed 19561004

  • Musgrove EA, Sutherland RL. Biological determinants of endocrine resistance in breast cancer. Nat Rev Cancer. 2009 Sep;9(9):631-43. doi: 10.1038/nrc2713.

    PubMed 19701242

  • Zardavas D, Irrthum A, Swanton C, Piccart M. Clinical management of breast cancer heterogeneity. Nat Rev Clin Oncol. 2015 Jul;12(7):381-94. doi: 10.1038/nrclinonc.2015.73. Epub 2015 Apr 21.

    PubMed 25895611

  • Meyerson M, Harlow E. Identification of G1 kinase activity for cdk6, a novel cyclin D partner. Mol Cell Biol. 1994 Mar;14(3):2077-86. doi: 10.1128/mcb.14.3.2077-2086.1994.

    PubMed 8114739

  • Coudreuse D, Nurse P. Driving the cell cycle with a minimal CDK control network. Nature. 2010 Dec 23;468(7327):1074-9. doi: 10.1038/nature09543.

    PubMed 21179163

  • O'Leary B, Finn RS, Turner NC. Treating cancer with selective CDK4/6 inhibitors. Nat Rev Clin Oncol. 2016 Jul;13(7):417-30. doi: 10.1038/nrclinonc.2016.26. Epub 2016 Mar 31.

    PubMed 27030077

  • Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017 Sep 1;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585. Epub 2017 Jun 3.

    PubMed 28580882

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ipatasertib 300mg, Fulvestrant 500g and Palbociclib 75mg-125mg in people with Metastatic Breast Cancer and ER+ Breast Cancer, run by Royal Marsden NHS Foundation Trust at 13 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess progression free survival (PFS) (time frame: Time from date of randomisation until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 51 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04920708, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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