2-METHOXY-N-{4-METHOXY-6-[(1H-PYRAZOL-1-YL)METHYL]-1,2-BENZOXAZOL-3-YL}BENZENE-1-SULFONAMIDE for Hormone receptor-positive HER2-negative advanced/metastatic breast cancer

Inclusion criteria

• {"criterion_text":"- At least 18 years of age (or the minimum age of consent in accordance with local regulations) at screening.\n- Histological confirmation of HR-positive HER2-negative breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent.\n- Must have received prior CDK4/6 inhibitor in one of the following settings as described below: i)\tCDK4/6i plus ET in the A/mBC setting; or ii)\tAdjuvant CDK4/6i plus ET with documented PD/recurrence during or within 12 months after the last dose of CDK4/6i. •\tIn addition, participants are eligible if they •\tPreviously received CDK4/6i or ET as a monotherapy, or in combination for rechallenge therapy in the A/mBC setting Note: fulvestrant or exemestane is allowed, but not required •\tHave received prior therapy targeting estrogen receptor 1 (ESR1) or breast cancer gene (BRCA)1/2.\n- Must provide a sufficient amount of representative formalin fixed, paraffin embedded (FFPE) tumor tissue specimen.\n- Measurable disease or non-measurable bone only disease as defined by RECIST v1.1.\n- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1. Note: Participants with ECOG 2 may be considered eligible if, per the investigator’s judgement and sponsor’s agreement, the participant has adequate organ function, life expectancy, and meets other protocol eligibility."}

Exclusion criteria

• {"criterion_text":"- Documented detectable phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)/AKT serine/threonine kinase 1 (AKT1)/phosphatase and tensin homolog deleted on chromosome 10 (PTEN) alterations.\n- Current use or anticipated need for any prohibited food, supplements or concomitant medication(s) (ie, other anti-cancer therapies, other endocrine therapies, cytochrome P450 2C9 [CYP2C9] and P450 3A4/5 [CYP3A4/5] inhibitors and inducers).\n- Renal impairment, hepatic dysfunction, or hematologic abnormalities.\n- Received greater than two prior lines of systemic therapy in the A/mBC setting.\n- Prior targeted therapy for one or more PIK3CA, AKT1, or PTEN alterations.\n- Had received any prior chemotherapy, including antibody drug conjugates (ADCs), in an A/mBC setting. Participants who have previously received chemotherapy in the (neo)adjuvant setting are not excluded from the study.\n- Major surgery within 4 weeks prior to randomization.\n- Systemic anti-cancer therapy or radiation within 2 weeks prior to randomization.\n- Visceral crisis or organ failure requiring immediate chemotherapy-based regimens (including antibody-drug conjugate [ADC]) or at risk of immediately life-threatening complications in the short term.\n- Any medical or psychiatric condition that may increase the risk of study participation or make the participant inappropriate for the study.\n- Known active uncontrolled or symptomatic central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease."}

Primary endpoints

• {"endpoint_text":"- PFS, defined as the time from the date of randomization to the date of first documented disease progression, as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause in the absence of progressive disease (PD), whichever occurs first.","definition_or_measurement_approach":"Time from randomization to first documented disease progression as determined by blinded independent central review (BICR) per RECIST v1.1, or death due to any cause in absence of PD; progression assessed by BICR per RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- OS, defined as the time from the date of randomization to the date of death due to any cause.","definition_or_measurement_approach":"Time from randomization to date of death from any cause."}
• {"endpoint_text":"- Objective Response (OR) by BICR per RECIST v1.1","definition_or_measurement_approach":"Objective response assessed by blinded independent central review (BICR) according to RECIST v1.1."}
• {"endpoint_text":"- DoR by BICR per RECIST v1.1","definition_or_measurement_approach":"Duration of response as assessed by BICR per RECIST v1.1."}
• {"endpoint_text":"- Clinical Benefit Response (CBR: complete response [CR], partial response [PR], or stable disease [SD] /non-CR/non-progression [non-PD] ≥24 weeks) by BICR per RECIST v1.1","definition_or_measurement_approach":"CBR defined as CR, PR, or SD/non-CR/non-PD ≥24 weeks as assessed by BICR per RECIST v1.1."}
• {"endpoint_text":"- Type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE v5.0]), seriousness of adverse events (AEs), any laboratory test or electrocardiogram (ECG) abnormalities, and characterization PF-07248144 effect on corrected QT interval (QTc) from baseline.","definition_or_measurement_approach":"Safety assessed by type/incidence/severity graded per NCI CTCAE v5.0, seriousness of AEs, lab and ECG abnormalities, and characterization of PF-07248144 effect on QTc from baseline."}
• {"endpoint_text":"- Ctrough (lowest plasma concentration before scheduled dose) of PF-07248144","definition_or_measurement_approach":"Pharmacokinetic measurement: trough (lowest) plasma concentration before scheduled dose of PF-07248144."}

Czechia

Earliest CTIS Part Ii Submission Date

17-09-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

33

Number Of Sites

7

Number Of Participants

3

Finland

Earliest CTIS Part Ii Submission Date

23-09-2025

Latest Decision Or Authorization Date

21-10-2025

Processing Time Days

28

Number Of Sites

4

Number Of Participants

4

Bulgaria

Earliest CTIS Part Ii Submission Date

02-09-2025

Latest Decision Or Authorization Date

27-10-2025

Processing Time Days

55

Number Of Sites

7

Number Of Participants

7

Poland

Earliest CTIS Part Ii Submission Date

22-09-2025

Latest Decision Or Authorization Date

26-10-2025

Processing Time Days

34

Number Of Sites

6

Number Of Participants

12

Spain

Earliest CTIS Part Ii Submission Date

03-10-2025

Latest Decision Or Authorization Date

27-10-2025

Processing Time Days

24

Number Of Sites

15

Number Of Participants

25

Italy

Earliest CTIS Part Ii Submission Date

14-07-2025

Latest Decision Or Authorization Date

27-10-2025

Processing Time Days

105

Number Of Sites

11

Number Of Participants

12

Sweden

Earliest CTIS Part Ii Submission Date

22-09-2025

Latest Decision Or Authorization Date

22-10-2025

Processing Time Days

30

Number Of Sites

3

Number Of Participants

2

Hungary

Earliest CTIS Part Ii Submission Date

01-09-2025

Latest Decision Or Authorization Date

22-10-2025

Processing Time Days

51

Number Of Sites

5

Number Of Participants

6

Slovakia

Earliest CTIS Part Ii Submission Date

23-09-2025

Latest Decision Or Authorization Date

20-10-2025

Processing Time Days

27

Number Of Sites

9

Number Of Participants

10

Belgium

Earliest CTIS Part Ii Submission Date

19-09-2025

Latest Decision Or Authorization Date

21-10-2025

Processing Time Days

32

Number Of Sites

13

Number Of Participants

13

Greece

Earliest CTIS Part Ii Submission Date

24-09-2025

Latest Decision Or Authorization Date

22-10-2025

Processing Time Days

28

Number Of Sites

7

Number Of Participants

7

France

Earliest CTIS Part Ii Submission Date

08-10-2025

Latest Decision Or Authorization Date

23-10-2025

Processing Time Days

15

Number Of Sites

24

Number Of Participants

24

Netherlands

Earliest CTIS Part Ii Submission Date

24-09-2025

Latest Decision Or Authorization Date

27-10-2025

Processing Time Days

33

Number Of Sites

12

Number Of Participants

4

Germany

Earliest CTIS Part Ii Submission Date

24-09-2025

Latest Decision Or Authorization Date

21-10-2025

Processing Time Days

27

Number Of Sites

13

Number Of Participants

24

Primary sponsor

Full Name

Pfizer Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Bioclinica Inc.

Responsibilities

Imaging/BICR

Name

Icon Clinical Research Limited

Name

Iqvia Rds Inc.

Responsibilities

ePROs

Third parties

• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging/BICR","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"central ECG, Home health services at Safety Follow-up (Vitals, pregnancy test, ePRO administration","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Iqvia Rds Inc.","duties_or_roles":"ePROs","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"ctDNA sample analysis","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"PK samples analisys","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Central final storage -Retained research samples","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Foundation Medicine GmbH","duties_or_roles":"Tumor tissue analysis","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Illingworth Research Group Limited","duties_or_roles":"Home health services at Safety Follow-up (Vitals, pregnancy test), ePRO administration","organisation_type":"Hospital/Clinic/Other health care facility"}