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ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL (ABIGAIL)

Primary Purpose

Breast Cancer Metastatic

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Abemaciclib
Paclitaxel
Letrozole
Fulvestrant
Sponsored by
MedSIR
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Signed informed consent form (ICF) prior to participation in any study-related activities.
  2. Male or female patients ≥18 years at the time of signing the ICF.
  3. Eastern Cooperative Oncology Group performance status of 0 or 1.
  4. Life expectancy of at least 24 weeks.
  5. Pre menopausal or peri menopausal women who are being treated with a luteinizing hormone-releasing hormone analog for at least 28 days prior to study entry (if shorter, post-menopausal levels of serum estradiol/follicle-stimulating hormone [FSH] must be confirmed analytically) or post menopausal women as defined by any of the following criteria:

    1. Documented bilateral oophorectomy;
    2. Age ≥60 years;
    3. Age <60 years and cessation of regular menses for ≥12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH level within the laboratory's reference range for post-menopausal females.
  6. Unresectable locally advanced or MBC that is not amenable to resection with curative intent.
  7. At least one of the following aggressive disease criteria:

    1. Presence of visceral disease;
    2. Either radiological as per RECIST v1.1 or clinical evidence of progressive disease (PD) on or within 36 months of completing adjuvant ET;
    3. High histological grade and/or PgR-negative status on primary tumor;
    4. Lactate dehydrogenase (LDH) >1.5 × the upper limit of normal (ULN).
  8. Histologically confirmed estrogen receptor and/or progesterone receptor (PgR) positive (with ≥1% positive stained cells according to National Comprehensive Cancer Network and American Society of Clinical Oncology guidelines) and HER2 negative (0 to 1+ by immunohistochemistry or 2+ and negative by in situ hybridization test) breast cancer based on local testing on the most recent analyzed biopsy.
  9. Measurable disease as per RECIST v 1.1 with at least one site of disease amenable to biopsy. Patients with bone lesions as the only sites of metastatic disease are not eligible, except for patients with identifiable soft tissue components, evaluable by cross sectional imaging techniques such as CT or magnetic resonance imaging (MRI), and that meet the definition of measurability according to RECIST v1.1.

    Note: Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation.

  10. Willingness and ability to provide a tumor biopsy from a metastatic site or the primary breast tumor at the time of the inclusion to perform exploratory studies. If not feasible, patient eligibility should be evaluated by Sponsor's qualified designee.
  11. Willingness to provide blood samples for exploratory studies at baseline, after two weeks of study treatment and at progression (or study treatment termination prior to start alternative anti cancer therapy).
  12. Patients relapsing on a cyclin-dependent kinase (CDK) 4/6 inhibitor based regimen in the neoadjuvant or adjuvant setting will be suitable for the study if disease progression is confirmed after at least 12 months following CDK 4/6 treatment completion.
  13. No prior systemic therapy for unresectable locally advanced or metastatic disease.
  14. Radiation therapy for metastatic disease is permitted but the patient must have fully recovered from the acute effects and at least 14 days must have elapsed between the last dose and randomization.

    Note: For limited-field radiotherapy, at least 7 days must have elapsed between the last dose and randomization.

  15. Resolution of all acute toxic effects of prior anti cancer therapy to Grade ≤1 as determined by the NCI-CTCAE v 5.0 (except for Grade ≤2 neuropathy, alopecia, or other toxicities not considered a safety risk for the patient at investigator's discretion) within at least 14 days prior to study Day 1.
  16. Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1, defined by the following:

    1. Hematological: White blood cell count >3.0 × 109/L; Absolute neutrophil count ≥1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1); Platelet count ≥100 × 109/L (without transfusion within 2 weeks prior to Cycle 1, Day 1); Hemoglobin >9.0 g/dL (without transfusion within 2 weeks prior to Cycle 1, Day 1).
    2. Hepatic:

    i. Serum albumin ≥ 3 g/dL; ii. Total bilirubin ≤ 1.5 × ULN (≤2 × ULN in the case of Gilbert's disease); iii. Aspartate transaminase and alanine transaminase ≤3.0 × ULN (in the case of liver metastases ≤5 × ULN); iv. Alkaline phosphatase ≤2.5 × ULN (in the case of liver and/or bone metastases ≤ 5 × ULN).

    c. Renal: i. Serum creatinine <1.5 × ULN or creatinine clearance ≥30 mL/min based on Cockcroft-Gault glomerular filtration rate estimation.

    d. Coagulation: i. Partial thromboplastin time (or activated partial thromboplastin time and international normalized ratio ≤1.5×ULN.

  17. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods, or two effective contraceptive methods, as defined in the protocol during the treatment period and for at least 3 weeks after the last dose of study treatment, and agreement to refrain from donating eggs during this same period. Women of childbearing potential must have a negative serum pregnancy test within 7 days before study treatment initiation.
  18. Male patients should also have their partners who are women of childbearing potential use highly effective contraceptive methods, or two effective contraceptive methods, as defined in the protocol during the treatment period and for at least 3 weeks after the last dose of study treatment and refrain from donating sperm during this period.
  19. Able to swallow oral medication.
  20. Patients who are reliable, willing to be available for the duration of the study and are willing to follow study procedures.

Exclusion Criteria:

  1. Known hypersensitivity to abemaciclib, letrozole, fulvestrant, paclitaxel, and/or any of their excipients.
  2. Are currently receiving an investigational drug in a clinical study or participating in any other type of medical research judged not to be scientifically or medically compatible with this study.

    Note: For patients who stopped receiving an investigational drug in another clinical study, a washout period of 21 days or 5-half-lives (whichever is shorter) must be observed before entering the trial.

  3. Formal contraindication to ET defined as visceral crisis and rapidly or symptomatic progressive visceral disease.
  4. Known concurrent malignancy or malignancy within 5 years of study enrollment except for carcinoma in situ of the cervix, non melanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the medical monitor is required.
  5. Known active brain metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for ≥4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for ≥14 days prior to first dose of study treatment.
  6. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
  7. Major surgical procedure within 14 days prior to treatment initiation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis.

    Note: Placement of central venous access catheter(s) (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted.

  8. Active bleeding diathesis, previous history of bleeding diathesis, or chronic anti-coagulation treatment (the use of low molecular weight heparin is allowed if used prophylactically).
  9. Serious and/or uncontrolled pre existing medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g., estimated creatinine clearance <30 ml/min], history of major surgical resection involving the stomach or small bowel, or pre-existing Crohn's disease or ulcerative colitis or a pre existing chronic condition resulting in baseline Grade 2 or higher diarrhea).
  10. Current known infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody [HBsAg] test and a positive hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  11. Active bacterial or fungal infection at the time of enrolment (requiring antibiotics or antifungal agents at time of initiating study treatment).
  12. History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
  13. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 3 weeks after the last dose of study treatment.

Sites / Locations

  • Instituto Europeo di Oncologia
  • Ospedale San GerardoRecruiting
  • Ospedale Guglielmo da SalicetoRecruiting
  • Azienda Ospedaliero-Universitaria Cittá de la Salute e della Scienza
  • Hospital Fernando da FonsecaRecruiting
  • Hospital de Santa Maria - Centro Hospitalar Lisboa Norte
  • Hospital Beatriz Ângelo
  • Hospital do Santo Antonio
  • Hospital Universitario Virgen del RocioRecruiting
  • Fundación Althaia ManresaRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Centro Oncoloxico de GaliciaRecruiting
  • Complejo Asistencial Universitario De LeónRecruiting
  • Complejo Hospitalario de NavarraRecruiting
  • Hospital Universitari de Sant Joan de ReusRecruiting
  • Hospital General Universitario de AlicanteRecruiting
  • Hospital Quiron Salud DexeusRecruiting
  • Hospital Universitario BasurtoRecruiting
  • Consorcio Hospitalario Provincial de CastellonRecruiting
  • Institut Catala D'Oncologia Girona - Hospital Josep TruetaRecruiting
  • Hospital Universitario San CecilioRecruiting
  • Hospital Universitario Arnau de VilanovaRecruiting
  • Hospital Ruber Juan BravoRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario Clinico San CarlosRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Quirónsalud Sagrado CorazónRecruiting
  • Hospital Clinico Universitario de ValenciaRecruiting
  • Hospital Quironsalud ValenciaRecruiting
  • Consorcio Hospital General Universitario de ValenciaRecruiting
  • Hospital Arnau de VilanovaRecruiting
  • Hospital Universitario Miguel ServetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional Arm (Arm A)

Control Arm (Arm B)

Arm Description

Abemaciclib 150 mg orally twice daily (BID) during each 28 day cycle combined with ET (2.5 mg letrozole, orally administered and taken daily during each 28-day cycle, or 500 mg fulvestrant, by intramuscular [IM] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter.

Paclitaxel 90 mg/m² infused over 1 hour on Days 1, 8, and 15 of the 28 day cycle, with at least a 6-day time span between separated doses.

Outcomes

Primary Outcome Measures

12-week overall response rate (ORR)
Complete response (CR) or partial response (PR), during the first 12 weeks of treatment as per blinded independent central review, using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.

Secondary Outcome Measures

ORR
The best overall response of CR or PR, as per investigator assessment and per blinded independent central review, using RECIST v 1.1.
Clinical benefit rate (CBR)
An objective response (CR or PR), or stable disease for at least 24 weeks, as per investigator assessment and blinded independent central review using RECIST v 1.1.
12-week progression-free survival (PFS) rate
The proportion of patients with disease progression or death from any cause, whichever occurs first during the first 12 weeks from randomization, as per investigator assessment and blinded independent central review using RECIST v 1.1.
PFS
The period of time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Time to response (TTR)
The time from randomization to time of the first objective tumor response (tumor shrinkage of ≥30%) observed in patients who achieved a CR or PR, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Duration of response (DoR)
The time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as per investigator assessment and per blinded independent central review using RECIST v 1.1.
Overall survival (OS)
The time from randomization to death from any cause, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Maximum tumor shrinkage (MTS)
The biggest decrease, or smallest increase if no decrease will be observed, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Time to first subsequent therapy (TFST)
The time from randomization to the time a patient starts his/her first line treatment (first subsequent therapy).
Time to second subsequent therapy (TSST)
The time from randomization to the time a patient starts his/her second line treatment (second subsequent therapy).
Time to first chemotherapy (TFC)
The time from randomization to the time a patient included in Arm A starts his/her first line chemotherapy.
Incidence of adverse events (AEs)
Number of patients with treatment-related AEs (Grade 3 and 4 AEs and serious adverse events [SAEs]) by using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.

Full Information

First Posted
October 7, 2020
Last Updated
June 8, 2023
Sponsor
MedSIR
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04603183
Brief Title
ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
Acronym
ABIGAIL
Official Title
A Randomized, 2-Arm, Open-Label, Ph-II Study of Abemaciclib Combined With ET w/ or w/o CT With Paclitaxel as 1L in Patients With Unresectable Locally Advanced or Metastatic HR(+)/HER2(-) BC With Aggressive Disease Criteria
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedSIR
Collaborators
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy with paclitaxel followed by maintenance therapy with abemaciclib combined with ET (letrozole or fulvestrant) in patients with previously untreated, unresectable locally advanced, or metastatic HR positive/HER2 negative breast cancer with aggressive disease criteria.
Detailed Description
The ABIGAIL study aims to provide consistent evidence that the combination of abemaciclib with ET -consisting of letrozole or fulvestrant-as first-line regimen is non-inferior to the optimal first-line chemotherapy -consisting of weekly paclitaxel-in terms of early ORR after the first 12 weeks of treatment in patients with HR-positive/HER2-negative ABC and at least one feature of aggressive disease associated with poor prognosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Arm (Arm A)
Arm Type
Experimental
Arm Description
Abemaciclib 150 mg orally twice daily (BID) during each 28 day cycle combined with ET (2.5 mg letrozole, orally administered and taken daily during each 28-day cycle, or 500 mg fulvestrant, by intramuscular [IM] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter.
Arm Title
Control Arm (Arm B)
Arm Type
Active Comparator
Arm Description
Paclitaxel 90 mg/m² infused over 1 hour on Days 1, 8, and 15 of the 28 day cycle, with at least a 6-day time span between separated doses.
Intervention Type
Drug
Intervention Name(s)
Abemaciclib
Other Intervention Name(s)
Verzenios
Intervention Description
Patients will receive abemaciclib 150 mg orally twice daily (BID) (300 mg daily, administered as six 50 mg tablets) during each 28 day cycle combined with either letrozole or fulvestrant.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Paclitaxel Teva
Intervention Description
Paclitaxel 90 mg/m² infused over 1 hour on Days 1, 8, and 15 of the 28 day cycle, with at least a 6-day time span between separated doses.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Intervention Description
Patients will receive 2.5 mg letrozole, orally administered and taken daily during each 28-day cycle combined with abemaciclib.
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Intervention Description
Patients will receive 500 mg fulvestrant, by intramuscular [IM] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter combined with abemaciclib.
Primary Outcome Measure Information:
Title
12-week overall response rate (ORR)
Description
Complete response (CR) or partial response (PR), during the first 12 weeks of treatment as per blinded independent central review, using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
ORR
Description
The best overall response of CR or PR, as per investigator assessment and per blinded independent central review, using RECIST v 1.1.
Time Frame
Baseline up to 24 months
Title
Clinical benefit rate (CBR)
Description
An objective response (CR or PR), or stable disease for at least 24 weeks, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Time Frame
Baseline up to 24 months
Title
12-week progression-free survival (PFS) rate
Description
The proportion of patients with disease progression or death from any cause, whichever occurs first during the first 12 weeks from randomization, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Time Frame
Baseline up to 12 weeks
Title
PFS
Description
The period of time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Time Frame
Baseline up to 24 months
Title
Time to response (TTR)
Description
The time from randomization to time of the first objective tumor response (tumor shrinkage of ≥30%) observed in patients who achieved a CR or PR, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Time Frame
Baseline up to 24 months
Title
Duration of response (DoR)
Description
The time from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as per investigator assessment and per blinded independent central review using RECIST v 1.1.
Time Frame
Baseline up to 24 months
Title
Overall survival (OS)
Description
The time from randomization to death from any cause, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Time Frame
Baseline up to 24 months
Title
Maximum tumor shrinkage (MTS)
Description
The biggest decrease, or smallest increase if no decrease will be observed, as per investigator assessment and blinded independent central review using RECIST v 1.1.
Time Frame
Baseline up to 24 months
Title
Time to first subsequent therapy (TFST)
Description
The time from randomization to the time a patient starts his/her first line treatment (first subsequent therapy).
Time Frame
Baseline up to 24 months
Title
Time to second subsequent therapy (TSST)
Description
The time from randomization to the time a patient starts his/her second line treatment (second subsequent therapy).
Time Frame
Baseline up to 24 months
Title
Time to first chemotherapy (TFC)
Description
The time from randomization to the time a patient included in Arm A starts his/her first line chemotherapy.
Time Frame
Baseline up to 24 months
Title
Incidence of adverse events (AEs)
Description
Number of patients with treatment-related AEs (Grade 3 and 4 AEs and serious adverse events [SAEs]) by using the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v.5.0.
Time Frame
Baseline up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent form (ICF) prior to participation in any study-related activities. Male or female patients ≥18 years at the time of signing the ICF. Eastern Cooperative Oncology Group performance status of 0 or 1. Life expectancy of at least 24 weeks. Pre menopausal or peri menopausal women who are being treated with a luteinizing hormone-releasing hormone analog for at least 28 days prior to study entry (if shorter, post-menopausal levels of serum estradiol/follicle-stimulating hormone [FSH] must be confirmed analytically) or post menopausal women as defined by any of the following criteria: Documented bilateral oophorectomy; Age ≥60 years; Age <60 years and cessation of regular menses for ≥12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and/or FSH level within the laboratory's reference range for post-menopausal females. Unresectable locally advanced or MBC that is not amenable to resection with curative intent. At least one of the following aggressive disease criteria: Presence of visceral disease; Either radiological as per RECIST v1.1 or clinical evidence of progressive disease (PD) on or within 36 months of completing adjuvant ET; High histological grade and/or PgR-negative status on primary tumor; Lactate dehydrogenase (LDH) >1.5 × the upper limit of normal (ULN). Histologically confirmed estrogen receptor and/or progesterone receptor (PgR) positive (with ≥1% positive stained cells according to National Comprehensive Cancer Network and American Society of Clinical Oncology guidelines) and HER2 negative (0 to 1+ by immunohistochemistry or 2+ and negative by in situ hybridization test) breast cancer based on local testing on the most recent analyzed biopsy. Measurable disease as per RECIST v 1.1 with at least one site of disease amenable to biopsy. Patients with bone lesions as the only sites of metastatic disease are not eligible, except for patients with identifiable soft tissue components, evaluable by cross sectional imaging techniques such as CT or magnetic resonance imaging (MRI), and that meet the definition of measurability according to RECIST v1.1. Note: Previously irradiated lesions can only be considered as measurable disease if disease progression has been unequivocally documented at that site since radiation. Willingness and ability to provide a tumor biopsy from a metastatic site or the primary breast tumor at the time of the inclusion to perform exploratory studies. If not feasible, patient eligibility should be evaluated by Sponsor's qualified designee. Willingness to provide blood samples for exploratory studies at baseline, after two weeks of study treatment and at progression (or study treatment termination prior to start alternative anti cancer therapy). Patients relapsing on a cyclin-dependent kinase (CDK) 4/6 inhibitor based regimen in the neoadjuvant or adjuvant setting will be suitable for the study if disease progression is confirmed after at least 12 months following CDK 4/6 treatment completion. No prior systemic therapy for unresectable locally advanced or metastatic disease. Radiation therapy for metastatic disease is permitted but the patient must have fully recovered from the acute effects and at least 14 days must have elapsed between the last dose and randomization. Note: For limited-field radiotherapy, at least 7 days must have elapsed between the last dose and randomization. Resolution of all acute toxic effects of prior anti cancer therapy to Grade ≤1 as determined by the NCI-CTCAE v 5.0 (except for Grade ≤2 neuropathy, alopecia, or other toxicities not considered a safety risk for the patient at investigator's discretion) within at least 14 days prior to study Day 1. Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1, defined by the following: Hematological: White blood cell count >3.0 × 109/L; Absolute neutrophil count ≥1.5 × 109/L (without granulocyte colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1); Platelet count ≥100 × 109/L (without transfusion within 2 weeks prior to Cycle 1, Day 1); Hemoglobin >9.0 g/dL (without transfusion within 2 weeks prior to Cycle 1, Day 1). Hepatic: i. Serum albumin ≥ 3 g/dL; ii. Total bilirubin ≤ 1.5 × ULN (≤2 × ULN in the case of Gilbert's disease); iii. Aspartate transaminase and alanine transaminase ≤3.0 × ULN (in the case of liver metastases ≤5 × ULN); iv. Alkaline phosphatase ≤2.5 × ULN (in the case of liver and/or bone metastases ≤ 5 × ULN). c. Renal: i. Serum creatinine <1.5 × ULN or creatinine clearance ≥30 mL/min based on Cockcroft-Gault glomerular filtration rate estimation. d. Coagulation: i. Partial thromboplastin time (or activated partial thromboplastin time and international normalized ratio ≤1.5×ULN. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods, or two effective contraceptive methods, as defined in the protocol during the treatment period and for at least 3 weeks after the last dose of study treatment, and agreement to refrain from donating eggs during this same period. Women of childbearing potential must have a negative serum pregnancy test within 7 days before study treatment initiation. Male patients should also have their partners who are women of childbearing potential use highly effective contraceptive methods, or two effective contraceptive methods, as defined in the protocol during the treatment period and for at least 3 weeks after the last dose of study treatment and refrain from donating sperm during this period. Able to swallow oral medication. Patients who are reliable, willing to be available for the duration of the study and are willing to follow study procedures. Exclusion Criteria: Known hypersensitivity to abemaciclib, letrozole, fulvestrant, paclitaxel, and/or any of their excipients. Are currently receiving an investigational drug in a clinical study or participating in any other type of medical research judged not to be scientifically or medically compatible with this study. Note: For patients who stopped receiving an investigational drug in another clinical study, a washout period of 21 days or 5-half-lives (whichever is shorter) must be observed before entering the trial. Formal contraindication to ET defined as visceral crisis and rapidly or symptomatic progressive visceral disease. Known concurrent malignancy or malignancy within 5 years of study enrollment except for carcinoma in situ of the cervix, non melanoma skin carcinoma, or stage I uterine cancer. For other cancers considered to have a low risk of recurrence, discussion with the medical monitor is required. Known active brain metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for ≥4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable, and without requirement of steroid treatment for ≥14 days prior to first dose of study treatment. Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study. Major surgical procedure within 14 days prior to treatment initiation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis. Note: Placement of central venous access catheter(s) (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted. Active bleeding diathesis, previous history of bleeding diathesis, or chronic anti-coagulation treatment (the use of low molecular weight heparin is allowed if used prophylactically). Serious and/or uncontrolled pre existing medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g., estimated creatinine clearance <30 ml/min], history of major surgical resection involving the stomach or small bowel, or pre-existing Crohn's disease or ulcerative colitis or a pre existing chronic condition resulting in baseline Grade 2 or higher diarrhea). Current known infection with HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV). Patients with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antibody [HBsAg] test and a positive hepatitis B core antibody [HBcAb] test, accompanied by a negative HBV DNA test) are eligible. Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA. Active bacterial or fungal infection at the time of enrolment (requiring antibiotics or antifungal agents at time of initiating study treatment). History of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through at least 3 weeks after the last dose of study treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Garrido
Phone
+34 667 762 735
Email
ana.garrido@medsir.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alicia García-Sanz
Phone
+ 34 932 214 135
Email
alicia.garcia@medsir.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Llombart-Cussac
Organizational Affiliation
Arnau de Vilanova Hospital, Valencia (Spain)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Colleoni
Facility Name
Ospedale San Gerardo
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marina Cazzaniga
Facility Name
Ospedale Guglielmo da Saliceto
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Cavanna
Facility Name
Azienda Ospedaliero-Universitaria Cittá de la Salute e della Scienza
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Hospital Fernando da Fonseca
City
Amadora
ZIP/Postal Code
2720-276
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonia Braga
Facility Name
Hospital de Santa Maria - Centro Hospitalar Lisboa Norte
City
Lisboa
ZIP/Postal Code
1600-190
Country
Portugal
Individual Site Status
Active, not recruiting
Facility Name
Hospital Beatriz Ângelo
City
Loures
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Branco
Facility Name
Hospital do Santo Antonio
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando Gonçalves
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
State/Province
Andalucía
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Ruiz, MD
Facility Name
Fundación Althaia Manresa
City
Manresa
State/Province
Barcelona
ZIP/Postal Code
08243
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clara Martínez, Dr.
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Morales, Dr.
Facility Name
Centro Oncoloxico de Galicia
City
A Coruña
State/Province
Coruña
ZIP/Postal Code
15009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manuel Ramos, Dr.
Facility Name
Complejo Asistencial Universitario De León
City
León
State/Province
Leon
ZIP/Postal Code
24073
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana López, Dr
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
State/Province
Pamplona/Iruña
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susana de la Cruz
Facility Name
Hospital Universitari de Sant Joan de Reus
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cinta Albacar, Dr
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Ponce, Dr.
Facility Name
Hospital Quiron Salud Dexeus
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Jose García Mosquera, MD
Facility Name
Hospital Universitario Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena Galve, Dr.
Facility Name
Consorcio Hospitalario Provincial de Castellon
City
Castellón De La Plana
ZIP/Postal Code
12002
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Martinez, Dr.
Facility Name
Institut Catala D'Oncologia Girona - Hospital Josep Trueta
City
Girona
ZIP/Postal Code
17007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helena Pla, Dr.
Facility Name
Hospital Universitario San Cecilio
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabel Blancas, Dr.
Facility Name
Hospital Universitario Arnau de Vilanova
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serafin Morales, Dr.
Facility Name
Hospital Ruber Juan Bravo
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Cortez
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elena López, Dr.
Facility Name
Hospital Universitario Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Ángel García, Dr.
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatriz Castelo, Dr.
Facility Name
Hospital Quirónsalud Sagrado Corazón
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Valero, Dr.
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maite Martínez, Dr.
Facility Name
Hospital Quironsalud Valencia
City
Valencia
ZIP/Postal Code
460137
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvador Blanch, Dr.
Facility Name
Consorcio Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vega Iranzo, Dr.
Facility Name
Hospital Arnau de Vilanova
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicente Carañana, Dr.
Facility Name
Hospital Universitario Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Antón

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL

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