Etude : GO40987 /



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Acronyme / Nom
Situation thérapeutique
Traitement
Cadre réglementaire
MÀJ
Présentation de l'étude
Acronyme / Nom : GO40987

Situation thérapeutique : Néoadjuvant

Traitement : Thérapie ciblée

Cadre réglementaire : RIPH1

Dernière MÀJ : 06/12/2021
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude de phase I, multicentrique, menée à court terme en préopératoire en ouvert sur le GDC-9545 chez des femmes ménopausées atteintes d’un cancer du sein positif aux récepteurs des oestrogènes

Spécialité : Seins, organes génitaux de la femme
Localisation : C50 - Tumeur maligne du sein
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of GDC-9545 in participants with Stage I-III operable estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, untreated breast cancer.

STUDY ARMS:
- Experimental: GDC-9545 Dose Level 1
- Experimental: GDC-9545 Dose Level 2
- Experimental: GDC-9545 Dose Level 3
GDC-9545 will be administered orally once daily (QD) starting on Day 1 up to and including the day of surgery (if allowed per local process) on Day 15 (+/-2 days).
Breast cancer surgery will take place on Day 15 (+/-2 days).

CURRENT PRIMARY OUTCOME:
Change from Baseline in Tumor Cell Proliferation Measured by Ki67 Expression Between Pre- and Post-Treatment Tumor Biopsy Samples [ Time Frame: Baseline and Day 14 or Day 15 ]

CURRENT SECONDARY OUTCOMES:
- Number of Participants with at Least One Adverse Event and by Severity, Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0) [ Time Frame: From Baseline to Day 43 ]
- Change from Baseline in Pulse Rate [ Time Frame: Baseline, Days 1, 8, 15, and 43 ]
- Change from Baseline in Systolic Blood Pressure [ Time Frame: Baseline, Days 1, 8, 15, and 43 ]
- Change from Baseline in Diastolic Blood Pressure [ Time Frame: Baseline, Days 1, 8, 15, and 43 ]
- Change from Baseline in Body Temperature [ Time Frame: Baseline, Days 1, 8, 15, and 43 ]
- Change from Baseline in Prothrombin Time (PT) [ Time Frame: Baseline, Days 1, 8, 15, and 43 ]
- Change from Baseline in Activated Partial Thromboplastin Time (aPTT) [ Time Frame: Baseline, Days 1, 8, 15, and 43 ]
- Change from Baseline in International Normalized Ratio (INR) [ Time Frame: Baseline, Days 1, 8, 15, and 43 ]
- Number of Participants with Laboratory Abnormalities in Hematology Tests by Highest Grade According to NCI-CTCAE v5.0 [ Time Frame: Baseline, Days 1, 8, and 15 ]
- Number of Participants with Laboratory Abnormalities in Blood Chemistry Tests by Highest Grade According to NCI-CTCAE v5.0 [ Time Frame: Baseline, Days 1, 8, and 15 - Plasma Concentration of GDC-9545 at Steady State [ Time Frame: Day 15 ]

Phase : I

Stade : Localisé

1
Informations libres de droit
Critères d'inclusion
Critères de non-inclusion
Informations libres de droit
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Ability to comply with the study protocol, in the investigator's judgment
- Histologically confirmed invasive breast carcinoma, with all of the following characteristics: Primary tumor greater than or equal to (≥)1.5 centimeters (cm) in largest diameter by ultrasound; Stage I-III operable breast cancer; Documentation confirming the absence of distant metastasis (M0) as determined by institutional practice.
- ER-positive tumor and HER2-negative breast cancer as per local laboratory testing
- Postmenopausal status
- Breast cancer eligible for primary surgery
- Submission of a representative tumor tissue specimen
- Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (≤)1
- Adequate organ function

Critères de non-inclusion : - Diagnosis of inflammatory breast cancer
- Diagnosis of bilateral breast cancer
- Concurrent use of hormone replacement therapies
- Previous systemic or local treatment for the primary breast cancer currently under investigation
- Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days prior to study entry
- Current treatment with any systemic anti-cancer therapies
- Major surgery within 4 weeks prior to enrollment
- Radiation therapy within 2 weeks prior to enrollment
- Diagnosis of any secondary malignancy within 3 years prior to enrollment, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
- Known HIV infection
- Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- History of allergy to GDC-9545 or any of its excipients
- Any condition requiring anti-coagulants, such as warfarin, heparin, or thrombolytic drugs
- History of documented hemorrhagic diathesis or coagulopathy
- History or presence of symptomatic bradycardia or sick sinus syndrome
- Baseline heart rate ≤55 beats per minute (bpm) prior to enrollment
- History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of prior myocardial infarction
- QT interval corrected through use of Fridericia's formula (QTcF) >470 milliseconds demonstrated by at least two ECGs >30 minutes apart
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome
- Current treatment with medications that are well known to prolong the QT interval
- History or presence of uncontrolled hypothyroidism
- Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
NCT03916744
Promoteur :
Genentech, Inc.
Type de sponsor : Industriel
Genentech, Inc.
00000 HORS FRANCE

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre Oscar Lambret - 3 Rue Frédéric Combemale - 59000 LILLE

Investigateur :
Docteur Audrey MAILLIEZ

TEC / ARC / IDE :
Unité Intégrée de Recherche Clinique
investigation@
o-lambret.fr
03.20.29.59.35

Statut de l'essai : OUVERT

MAJ : 09/07/2020