Crizotinib in Lobular Breast, Diffuse Gastric and Triple Negative Lobular Breast Cancer or CDH1-mutated Solid Tumours
NCT ID: NCT03620643
Last Updated: 2025-10-30
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
33 participants
Study Classification
INTERVENTIONAL
Study Start Date
2019-05-09
Study Completion Date
2024-08-30
Brief Summary
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The purpose of this study was to find out how effective the combination of crizotinib and fulvestrant was in shrinking lobular breast cancer tumours. The investigators also assessed the side effects of the combination of crizotinib tablets and fulvestrant injections. The side effects and the doses of crizotinib and fulvestrant had already been evaluated in large clinical trials, but this was the first time these two drugs had been combined together.
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Detailed Description
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This clinical study was looking at whether a drug called crizotinib, which is used in some patients with lung cancer, was effective in a sub-type of breast cancer, called lobular breast cancer. As the majority of lobular breast cancers are oestrogen receptor positive (ER+ve), crizotinib was combined with a second drug, fulvestrant, to try to block tumour growth that is driven by oestrogen.
Crizotinib targets cancers with genetic changes in two genes called ALK and ROS1. Lung cancers with changes in these genes usually get smaller when treated with crizotinib. Laboratory work at the Institute of Cancer Research has shown that lobular breast cancer cells, due to a mutation in a different gene called CDH1, appear to be similarly affected by crizotinib.
Fulvestrant is an oestrogen receptor down regulator and blocks the effects of oestrogen on oestrogen receptor positive (ER+ve) breast cancer cells. Fulvestrant is an established and approved anti-hormone therapy which patients with breast cancers are receiving in the clinic. It is possible that the combination of crizotinib and an anti-oestrogen agent will shrink the tumour(s) more effectively and prevent further growth. Because fulvestrant is only effective in post-menopausal women, if participants had not yet gone through the menopause, participants needed to start (or continue to receive) a monthly injection under the skin to temporarily stop the function of the participant's ovaries to be eligible to take part in the trial.
This injection is called goserelin and had to be started at least 4 weeks before the first day of treatment on the trial.
The overall aims of this clinical study were to find out:
* The proportion of patients whose tumour(s) shrink when they are treated with crizotinib and fulvestrant
* The safety and tolerability of fulvestrant in combination with crizotinib, to determine that they can be given together without unacceptable side effects
* What the drugs do to the tumours, which will help us decide which patients may benefit from this combination in the future
Crizotinib targets cancers with genetic changes in two genes called ALK and ROS1. Lung cancers with changes in these genes usually get smaller when treated with crizotinib. Laboratory work at the Institute of Cancer Research has shown that lobular breast cancer cells, due to a mutation in a different gene called CDH1, appear to be similarly affected by crizotinib.
Fulvestrant is an oestrogen receptor down regulator and blocks the effects of oestrogen on oestrogen receptor positive (ER+ve) breast cancer cells. Fulvestrant is an established and approved anti-hormone therapy which patients with breast cancers are receiving in the clinic. It is possible that the combination of crizotinib and an anti-oestrogen agent will shrink the tumour(s) more effectively and prevent further growth. Because fulvestrant is only effective in post-menopausal women, if participants had not yet gone through the menopause, participants needed to start (or continue to receive) a monthly injection under the skin to temporarily stop the function of the participant's ovaries to be eligible to take part in the trial.
This injection is called goserelin and had to be started at least 4 weeks before the first day of treatment on the trial.
The overall aims of this clinical study were to find out:
* The proportion of patients whose tumour(s) shrink when they are treated with crizotinib and fulvestrant
* The safety and tolerability of fulvestrant in combination with crizotinib, to determine that they can be given together without unacceptable side effects
* What the drugs do to the tumours, which will help us decide which patients may benefit from this combination in the future
Conditions
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Lobular Breast Carcinoma
Gastric Cancer
Triple Negative Breast Cancer
CDH1 Gene Mutation
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
This multi-centre study design will aim to complete recruitment over 18 months from six high volume centres including the Royal Marsden. Parallel recruitment to breast and basket cancer cohorts will take place for this study.
Primary Study Purpose
OTHER
Blinding Strategy
SINGLE
Participants
Study Groups
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Crizotinib Oral Capsule [Xalkori] monotherapy
Arm 1 - Basket cohort (n=29 participants) were treated with Crizotinib Oral Capsule \[Xalkori\] (250 mg b.d) taken as monotherapy on a continuous dosing schedule. One treatment cycle for Crizotinib is 28 days long.
Group Type
ACTIVE_COMPARATOR
Crizotinib Oral Capsule [Xalkori]
Intervention Type
DRUG
Crizotinib 250 mg Crizotinib 200mg
Crizotinib Oral Capsule [Xalkori] plus Fulvestrant injection
Arm 2 - Lobular Breast Cancer cohort (n=29 participants) were treated with combination therapy. The combination therapy included; Crizotinib Oral Capsule \[Xalkori\] (250mg b.d.) plus Fulvestrant 50 mg/mL Prefilled Syringe \[Faslodex or generic\] intramuscular (IM) injection (500 mg per 1 cycle (q28 days, plus loading dose on day 15).
Group Type
ACTIVE_COMPARATOR
Crizotinib Oral Capsule [Xalkori]
Intervention Type
DRUG
Crizotinib 250 mg Crizotinib 200mg
Fulvestrant 50 MG/ML Prefilled Syringe [Faslodex or generic]
Intervention Type
DRUG
Fulvestrant (Faslodex or generic) is supplied as two 5-mL clear neutral glass (Type 1) barrels, each containing 250mg/5mL of fulvestrant solution for intramuscular injection and fitted with a tamper evident closure.
Interventions
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Crizotinib Oral Capsule [Xalkori]
Crizotinib 250 mg Crizotinib 200mg
Intervention Type
DRUG
Fulvestrant 50 MG/ML Prefilled Syringe [Faslodex or generic]
Fulvestrant (Faslodex or generic) is supplied as two 5-mL clear neutral glass (Type 1) barrels, each containing 250mg/5mL of fulvestrant solution for intramuscular injection and fitted with a tamper evident closure.
Intervention Type
DRUG
Other Intervention Names
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Xalkori
Faslodex
Eligibility Criteria
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Inclusion Criteria
\- Patients with histological diagnosis of E-cadherin negative inoperable or metastatic diffuse gastric cancer (basket cohort), Or inoperable or metastatic triple negative lobular breast cancer (basket cohort) Or inoperable or metastatic CDH1-mutated solid tumour with allele fraction ≥20% (basket cohort) Or recurrent inoperable locally advanced ER positive/HER2 negative lobular breast cancer (breast cohort).
Assessment of E-cadherin, ER and HER2 status as per local assessment.
\- Lobular breast cancer patients previously treated with at least one prior line of therapy including at least one prior line of hormone therapy for advanced disease, but no more than three prior lines of chemotherapy for advanced disease.
Gastric cancer, triple negative lobular breast cancer or CDH1-mutated solid tumour patients previously treated with at least one prior therapy for advanced disease OR relapsing within one year of completing (neo) adjuvant chemotherapy OR unsuitable for chemotherapy in the opinion of the investigator (for example patient choice not to have chemotherapy, or no suitable chemotherapy agent).
* Measurable disease (RECIST 1.1)
* Haematological and biochemical indices within the ranges shown in protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.
* Female patients with child-bearing potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial. Both male and female patients of reproductive potential must agree to use two forms of highly effective contraception (see below) for 2 weeks before starting the study treatment, throughout the treatment period and for 90 days after discontinuation of treatment with crizotinib and 2 years after the last dose of fulvestrant.
NOTE: it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments
The oral contraceptive pill may be ineffective when taken with crizotinib so is not an acceptable means of contraception for female patients during this study but can be used by female partners of male patients.
* 18 years of age or over with written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
* World Health Organisation (WHO) performance status 0,1 or 2
* Estimated life expectancy of at least 3 months in the opinion of the investigator
* Pre-/peri-menopausal ER+ lobular breast cancer patients must be willing to receive gosarelin injections every 28 days.
* Signed and dated informed consent.
* Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other procedures.
Assessment of E-cadherin, ER and HER2 status as per local assessment.
\- Lobular breast cancer patients previously treated with at least one prior line of therapy including at least one prior line of hormone therapy for advanced disease, but no more than three prior lines of chemotherapy for advanced disease.
Gastric cancer, triple negative lobular breast cancer or CDH1-mutated solid tumour patients previously treated with at least one prior therapy for advanced disease OR relapsing within one year of completing (neo) adjuvant chemotherapy OR unsuitable for chemotherapy in the opinion of the investigator (for example patient choice not to have chemotherapy, or no suitable chemotherapy agent).
* Measurable disease (RECIST 1.1)
* Haematological and biochemical indices within the ranges shown in protocol. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes in the trial.
* Female patients with child-bearing potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial. Both male and female patients of reproductive potential must agree to use two forms of highly effective contraception (see below) for 2 weeks before starting the study treatment, throughout the treatment period and for 90 days after discontinuation of treatment with crizotinib and 2 years after the last dose of fulvestrant.
NOTE: it is only considered highly effective if the patient is refraining from sexual intercourse during the entire period of risk associated with the study treatments
The oral contraceptive pill may be ineffective when taken with crizotinib so is not an acceptable means of contraception for female patients during this study but can be used by female partners of male patients.
* 18 years of age or over with written (signed and dated) informed consent and be capable of co-operating with treatment and follow-up.
* World Health Organisation (WHO) performance status 0,1 or 2
* Estimated life expectancy of at least 3 months in the opinion of the investigator
* Pre-/peri-menopausal ER+ lobular breast cancer patients must be willing to receive gosarelin injections every 28 days.
* Signed and dated informed consent.
* Patients willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other procedures.
Exclusion Criteria
* Systemic chemotherapy or investigational medicinal products during the previous four weeks, or hormonal therapy within 7 days except luteinizing hormone-releasing hormone (LHRH) analogues for ovarian suppression. Bisphosphonates or RANK ligand antagonists are permitted for the management of bone metastases.
* Previous treatment with any agent that inhibits ROS1
* Mixed ductal/lobular breast cancer, unless both ductal and lobular components are CDH1 negative by local assessment
* Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks or radiation therapy within 14 days prior to study entry
* Patients with known symptomatic brain metastases requiring steroids, untreated brain metastases or spinal cord compression
* Any of the following within 12 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack. Uncontrolled hypertension or cardiac dysrhythmia including atrial fibrillation.
* QT interval, corrected \>470 ms or the use of bradycardic agents, drugs which prolong the QT interval and/or anti-arrhythmic agents within 12 days before the first dose of crizotinib or during study treatment.
* Use of drugs that are known potent cytochrome P450 (CYP) 3A4 inhibitors or moderate or strong CYP 3A4 inducers within 12 days before the first dose of crizotinib. Us of CYP3A4 substrates with a narrow therapeutic index (such as ciclosporin) is also not permitted within 12 days prior or during the study treatment.
* Patients on warfarin. Patients requiring anticoagulation for rate-controlled AF or previous venous thromboembolism should be switched to low-molecular weight heparin.
* Known HIV or AIDS-related illness, active infection requiring systemic therapy, or positive HBV or HCV test indicating acute or chronic infection.
* Inability or unwillingness to swallow pills, or (for patients receiving fulvestrant) receive IM injections.
* Other severe acute or chronic medical condition or psychiatric condition, recent or active suicidal ideation or behaviour, or end stage renal disease on haemodialysis, or laboratory abnormality that may increase the risk associated with study participation or investigational products administration or may interfere with the interpretation of results and, in the judgment of the Investigator, would make the patient inappropriate study entry.
* Persisting toxicity related to prior therapy \>Grade 1 (except for stable peripheral neuropathy grade ≤2 or alopecia grade ≤2).
* Pregnancy or lactation.
* Diagnosis of other malignancy within 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix, or low-grade (Gleason ≤6) prostate cancer.
* Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.
* Immunocompromised status due to current known active infection with HIV or due to the use of immunosuppressive therapies for other conditions
* Known prior or suspected hypersensitivity to investigational products or to any of the excipients.
* Patients at risk for gastrointestinal perforation (due to e.g., history of diverticulitis).
* Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
* Previous treatment with any agent that inhibits ROS1
* Mixed ductal/lobular breast cancer, unless both ductal and lobular components are CDH1 negative by local assessment
* Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks or radiation therapy within 14 days prior to study entry
* Patients with known symptomatic brain metastases requiring steroids, untreated brain metastases or spinal cord compression
* Any of the following within 12 months prior to study entry: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack. Uncontrolled hypertension or cardiac dysrhythmia including atrial fibrillation.
* QT interval, corrected \>470 ms or the use of bradycardic agents, drugs which prolong the QT interval and/or anti-arrhythmic agents within 12 days before the first dose of crizotinib or during study treatment.
* Use of drugs that are known potent cytochrome P450 (CYP) 3A4 inhibitors or moderate or strong CYP 3A4 inducers within 12 days before the first dose of crizotinib. Us of CYP3A4 substrates with a narrow therapeutic index (such as ciclosporin) is also not permitted within 12 days prior or during the study treatment.
* Patients on warfarin. Patients requiring anticoagulation for rate-controlled AF or previous venous thromboembolism should be switched to low-molecular weight heparin.
* Known HIV or AIDS-related illness, active infection requiring systemic therapy, or positive HBV or HCV test indicating acute or chronic infection.
* Inability or unwillingness to swallow pills, or (for patients receiving fulvestrant) receive IM injections.
* Other severe acute or chronic medical condition or psychiatric condition, recent or active suicidal ideation or behaviour, or end stage renal disease on haemodialysis, or laboratory abnormality that may increase the risk associated with study participation or investigational products administration or may interfere with the interpretation of results and, in the judgment of the Investigator, would make the patient inappropriate study entry.
* Persisting toxicity related to prior therapy \>Grade 1 (except for stable peripheral neuropathy grade ≤2 or alopecia grade ≤2).
* Pregnancy or lactation.
* Diagnosis of other malignancy within 5 years, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or cervix, or low-grade (Gleason ≤6) prostate cancer.
* Is a participant or plans to participate in another interventional clinical trial, whilst taking part in this study. Participation in an observational trial would be acceptable.
* Immunocompromised status due to current known active infection with HIV or due to the use of immunosuppressive therapies for other conditions
* Known prior or suspected hypersensitivity to investigational products or to any of the excipients.
* Patients at risk for gastrointestinal perforation (due to e.g., history of diverticulitis).
* Any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Pfizer
INDUSTRY
Sponsor Role
collaborator
Breast Cancer Now
OTHER
Sponsor Role
collaborator
Royal Marsden NHS Foundation Trust
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Professor Peter Schmid
Role: STUDY_CHAIR
St Bart's Hospital
Locations
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Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Site Status
Royal Marsden NHS Foundation Trust
London, , United Kingdom
Site Status
Guys and St Thomas NHS Foundation Trust
London, , United Kingdom
Site Status
University College London Hospital
London, , United Kingdom
Site Status
The Christie NHS Foundation Trust
Manchester, , United Kingdom
Site Status
Countries
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United Kingdom
References
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Shaw AT, Ou SH, Bang YJ, Camidge DR, Solomon BJ, Salgia R, Riely GJ, Varella-Garcia M, Shapiro GI, Costa DB, Doebele RC, Le LP, Zheng Z, Tan W, Stephenson P, Shreeve SM, Tye LM, Christensen JG, Wilner KD, Clark JW, Iafrate AJ. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014 Nov 20;371(21):1963-71. doi: 10.1056/NEJMoa1406766. Epub 2014 Sep 27.
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Lennerz JK, Kwak EL, Ackerman A, Michael M, Fox SB, Bergethon K, Lauwers GY, Christensen JG, Wilner KD, Haber DA, Salgia R, Bang YJ, Clark JW, Solomon BJ, Iafrate AJ. MET amplification identifies a small and aggressive subgroup of esophagogastric adenocarcinoma with evidence of responsiveness to crizotinib. J Clin Oncol. 2011 Dec 20;29(36):4803-10. doi: 10.1200/JCO.2011.35.4928. Epub 2011 Oct 31.
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Lauren Christine Harshman, K.P.G., Laura Polacek, Mary-Ellen Taplin, Atish Dipankar Choudhury, Mark M Pomerantz, Joaquim Bellmunt, Channing Yu, Zijie Sun, Sandy Srinivas, Philip W. Kantoff, Christopher Sweeney. An investigator-initiated phase I study of crizotinib in combination with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) before or after progression on docetaxel. in ASCO Annual Meeting. 2016. Chicago: J Clin Oncol.
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E. L. Kwak, D.R.C., J. Clark, G. I. Shapiro, R. G. Maki, M. J. Ratain, B. Solomon, Y. Bang, S. Ou, R. Salgia. Clinical activity observed in a phase I dose escalation trial of an oral c-met and ALK inhibitor, PF-02341066. in ASCO Annual Meeting. 2009. J Clin Oncol.
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Di Leo A, Jerusalem G, Petruzelka L, Torres R, Bondarenko IN, Khasanov R, Verhoeven D, Pedrini JL, Smirnova I, Lichinitser MR, Pendergrass K, Garnett S, Lindemann JP, Sapunar F, Martin M. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol. 2010 Oct 20;28(30):4594-600. doi: 10.1200/JCO.2010.28.8415. Epub 2010 Sep 20.
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Telford BJ, Chen A, Beetham H, Frick J, Brew TP, Gould CM, Single A, Godwin T, Simpson KJ, Guilford P. Synthetic Lethal Screens Identify Vulnerabilities in GPCR Signaling and Cytoskeletal Organization in E-Cadherin-Deficient Cells. Mol Cancer Ther. 2015 May;14(5):1213-23. doi: 10.1158/1535-7163.MCT-14-1092. Epub 2015 Mar 16.
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Okines A, Irfan T, Asare B, Mohammed K, Osin P, Nerurkar A, Smith IE, Parton M, Ring A, Johnston S, Turner NC. Clinical outcomes in patients with triple negative or HER2 positive lobular breast cancer: a single institution experience. Breast Cancer Res Treat. 2022 Apr;192(3):563-571. doi: 10.1007/s10549-021-06432-z. Epub 2022 Feb 4.
Reference Type
DERIVED
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CCR4684
Identifier Type: -
Identifier Source: org_study_id
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UNKNOWN
PHASE1
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
NCT05646862
ACTIVE_NOT_RECRUITING
PHASE3
An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.
NCT02657343
COMPLETED
PHASE1/PHASE2
Fulvestrant With Ribociclib Versus Physician's Choice Treatments Recurred After Completion of Adjuvant Cyclin-Dependent Kinase 4/6 Inhibitors in HR+, HER2- Metastatic Breast Cancer
NCT06849947
NOT_YET_RECRUITING
PHASE2
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
NCT06726148
RECRUITING
PHASE1/PHASE2
A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer
NCT02053636
COMPLETED
PHASE2
Clinical Study of Fulvestrant Combined With Chidamide in the Treatment of Hormone Receptor-positive Advanced Breast Cancer Resistant to CDK4/6 Inhibitors
NCT05191914
UNKNOWN
PHASE4
A Study of SHR-A1811 and Fulvestrant, With or Without HS-10352, in Locally Advanced or Metastatic Breast Cancer Patients
NCT06788197
NOT_YET_RECRUITING
PHASE1/PHASE2
An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer
NCT03243331
COMPLETED
PHASE1
PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
NCT05759546
RECRUITING
PHASE2
Phase 1 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-201
NCT06341647
WITHDRAWN
PHASE1
Phase II Study of Erlotinib, an EGFR Inhibitor in Metastatic EGFR-positive 'Triple Receptor-negative' Breast Cancer
NCT00739063
TERMINATED
PHASE2
BGB-43395 Alone or as Part of Combination Therapies in Chinese Participants With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
NCT06253195
ACTIVE_NOT_RECRUITING
PHASE1
Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors
NCT06929325
NOT_YET_RECRUITING
PHASE3
Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
NCT04650581
ACTIVE_NOT_RECRUITING
PHASE3
Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
NCT05816655
RECRUITING
PHASE2
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
NCT06625775
RECRUITING
PHASE1
G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
NCT02983071
UNKNOWN
PHASE1/PHASE2
PARP Inhibitor With CDK4/ 6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
NCT06612814
ACTIVE_NOT_RECRUITING
PHASE3