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Hormone Therapy
GDC-9545 + Palbociclib/LHRH Agonist for Breast Cancer
Phase 1
Waitlist Available
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable disease, or evaluable bone disease; that is, bone lesions that are lytic or mixed (lytic + sclerotic) in the absence of measurable lesion
Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent or with metastatic disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for all cohorts, except for cohort x: from the first occurrence of a documented objective response until first observation of disease progression or death from any cause on study, whichever occurs first (up to 84 months)
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of the drug GDC-9545 as a treatment for people with a certain type of breast cancer.
Who is the study for?
This trial is for postmenopausal women with advanced or metastatic ER-positive/HER2-negative breast cancer. Participants should have an ECOG Performance Status ≤1, no more than two prior treatments for their condition, and adequate organ function. They must not have had certain recent surgeries or therapies, severe medical conditions that could affect safety or results, known HIV infection, significant heart disease risks, untreated brain metastases, or a history of certain malignancies within the last three years.Check my eligibility
What is being tested?
The study tests GDC-9545's effectiveness and safety alone and in combination with palbociclib and/or LHRH agonist in treating estrogen receptor-positive breast cancer. It will assess how the body processes these drugs (PK), their impact on the body (PD), and preliminary anti-tumor activity through various stages including dose escalation.See study design
What are the potential side effects?
Potential side effects may include typical reactions to hormone therapies such as hot flashes, fatigue, joint pain; from palbociclib like low white blood cell counts leading to increased infection risk; gastrointestinal issues; possible liver function changes; and other common medication-related adverse events.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have cancer that can be measured or seen in my bones.
Select...
My breast cancer has returned or spread and cannot be removed or cured with surgery or radiation.
Select...
My breast cancer is HER2-negative.
Select...
My doctor can safely take samples of my cancer before and during treatment.
Select...
I am fully active or can carry out light work.
Select...
All side effects from my previous treatments have mostly gone away.
Select...
My organs are working well.
Select...
My advanced cancer does not respond to or cannot tolerate standard treatments.
Select...
I have had 2 or fewer treatments for advanced breast cancer.
Select...
It's been over 2 months since I last used tamoxifen and over 6 months since I last used fulvestrant.
Select...
I have gone through menopause.
Select...
My tumor is estrogen receptor positive.
Select...
It has been over 2 weeks since my last cancer treatment.
Select...
I have not been treated with CDK4/6 inhibitors before.
Select...
My breast cancer is ER-positive/HER2-negative and has worsened despite hormone therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for all cohorts, except for cohort x: from the first occurrence of a documented objective response until first observation of disease progression or death from any cause on study, whichever occurs first (up to 84 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for all cohorts, except for cohort x: from the first occurrence of a documented objective response until first observation of disease progression or death from any cause on study, whichever occurs first (up to 84 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline in Body Temperature Over Time
Change from Baseline in Diastolic Blood Pressure Over Time
Change from Baseline in ECG Results Over Time: PR Duration
+14 moreSecondary outcome measures
Clinical Benefit Rate
Duration of Response
Percentage of Participants with Objective Response
+3 moreSide effects data
From 2023 Phase 2 trial • 55 Patients • NCT0300797996%
White blood cell count decreased
87%
Neutrophil count decreased
80%
Anemia
74%
Lymphocyte count decreased
67%
Hypertension
61%
Fatigue
56%
Diarrhea
54%
Nausea
43%
Platelet count decreased
41%
Alopecia
39%
Headache
39%
Hot flashes
37%
Dizziness
37%
Insomnia
37%
Dyspepsia
35%
Arthralgia
35%
Anorexia
35%
Hyponatremia
35%
Cough
35%
Aspartate aminotransferase increased
33%
Edema limbs
33%
Alanine aminotransferase increased
33%
Creatinine increased
31%
Hyperkalemia
31%
Hypercalcemia
31%
Mucositis oral
31%
Vomiting
31%
Hypocalcemia
30%
Dyspnea
30%
Alkaline phosphatase increased
30%
Back pain
28%
Constipation
26%
Pain
26%
Hypokalemia
24%
Chills
20%
Hyperglycemia
20%
Dysgeusia
20%
Depression
20%
Myalgia
20%
Fall
19%
Pain in extremity
19%
Rash maculopapular
17%
Upper respiratory infection
17%
Peripheral sensory neuropathy
17%
Sinusitis
17%
Fever
17%
Anxiety
17%
Sore throat
15%
Hypoalbuminemia
13%
Hyperhidrosis
13%
Urinary tract infection
13%
Bone pain
13%
Nasal congestion
13%
Dry skin
11%
Hypernatremia
11%
Allergic rhinitis
11%
Weight loss
9%
Epistaxis
9%
Hypophosphatemia
9%
COVID-19
9%
Dysphagia
7%
Non-cardiac chest pain
7%
Tooth infection
7%
Skin infection
7%
Blurred vision
7%
Vertigo
7%
Breast pain
7%
Bronchitis
7%
Postnasal drip
7%
Common cold
7%
Neck pain
7%
Lymphedema
6%
Itchy skin
6%
Death
6%
Dehydration
6%
Cellulitis
6%
Knee pain
6%
Cataract
6%
Psoriasis
6%
Body aches
6%
Buttock pain
6%
Lung infection
6%
Allergic reaction
6%
Hypoglycemia
6%
Urinary frequency
6%
Osteopenia
6%
Rash acneiform
6%
Gout
6%
Bug bite
6%
Arthritis
6%
Thromboembolic event
4%
Memory impairment
4%
Flu-like symptoms
4%
Edema trunk
4%
Sinus pain
4%
Back spasms
4%
Watering eyes
4%
Vaginal dryness
4%
Dry eye
4%
Head injury
4%
Burn
4%
Skin bump
4%
Right arm numbness
4%
Nodule
4%
Hip pain
4%
Peripheral motor neuropathy
4%
Hypothyroidism
4%
Broken tooth
4%
Abdominal pain
4%
Dry lips
4%
Toothache
4%
Tick bite
4%
Extremity infection
4%
Hypomagnesemia
4%
Generalized muscle weakness
4%
Pleural effusion
4%
Sleep apnea
4%
Right thumb bump
4%
Osteonecrosis of jaw
4%
Chest pain - cardiac
4%
Acute kidney injury
4%
Muscle cramp
4%
Muscle spasm
4%
Gastroesophageal reflux disease
4%
Bruising
4%
Burn - left hand
4%
Brittle nail
2%
Hoarseness
2%
Urine discoloration
2%
Lung cancer
2%
Oral fissure
2%
Cold sweats
2%
Intrascapular pain
2%
Eye lid pain
2%
Paronychia
2%
Vaginal itching
2%
Sinus congestion
2%
Pharyngitis
2%
Yeast infection
2%
Puncture wound
2%
COPD
2%
Vaginal infection
2%
Activated partial thromboplastin time prolonged
2%
Shoulder nodule
2%
Blood bilirubin increased
2%
Hypermagnesemia
2%
Bladder infection
2%
Diverticulitis
2%
Flank pain
2%
Paresthesia
2%
Cognitive disturbance
2%
Sinus tachycardia
2%
Localized edema
2%
Wrist pain
2%
Fever blister
2%
Radiation recall reaction (dermatologic)
2%
Facial nerve disorder
2%
Agitation
2%
Fungal toe infection
2%
Respiratory syncytial virus (RSV)
2%
Photophobia
2%
Hemorrhoids
2%
Sepsis
2%
Fracture
2%
Vaginal discharge
2%
Generalized weakness
2%
Leg pain
2%
Wrist fracture
2%
Bilateral nares sores
2%
Rhinovirus
2%
Laryngeal inflammation
2%
Erythema right breast
2%
Wound infection
2%
Hyperuricemia
2%
Urinary retention
2%
Erythema multiforme
2%
Nail loss
2%
Peeling lips
2%
Vaginal itch
2%
Head injury - upper left occipital swelling
2%
Acoustic neuroma
2%
Eye lid pain/soreness
2%
Open cutaneous area left breast
2%
Peeling skin palms of hands
2%
Mole pain
2%
Itchy scalp
2%
Spinal fracture
2%
Asthma
2%
Hand cramps
2%
Left hand puncture wound
2%
C. difficile
2%
Gait disturbance
2%
Myocardial infarction
2%
Red eye
2%
Groin pain
2%
Superficial thrombophlebitis
2%
Paronychia - infection right middle
2%
Snake bite
2%
Hemoglobin increased
2%
Muscle weakness lower limb
2%
Right arm pain
2%
Mitral valve disease
2%
Tinnitus
2%
Vestibular schwannoma
2%
Dry mouth
2%
Oral dysesthesia
2%
Oral pain
2%
Stomach pain
2%
Ulcerative colitis
2%
Acute bronchitis
2%
Otitis media
2%
INR increased
2%
Lymphocyte count increased
2%
Bilateral leg pain
2%
Chest wall pain
2%
Left sided flank pain
2%
Sternum pain
2%
ADHD
2%
Confusion
2%
Sacroliac joint pain
2%
Shoulder pain
2%
Hallucinations
2%
Mood swings
2%
Nasal dryness
2%
Productive cough
2%
Voice alteration
2%
Hypotension
2%
Cold sensitivity
2%
Sciatic pain
2%
Nasal drainage
2%
Heart failure
2%
Skin bumps
2%
Skin hypopigmentation
2%
Leg stiffness
2%
Asystole
2%
Failure to thrive
2%
Intracranial hemorrhage
2%
Gastric ulcer
2%
Gingival pain
2%
Hematochezia
2%
Hemorrhoidal hemorrhage
2%
Dilation of appendix with periappendiceal fat stranding seen on CT
2%
Edema face
2%
Yeast infection under right breast
2%
Weight gain
2%
Spasticity
2%
Syncope
2%
Blister
2%
Sores bilateral nares
2%
Stomach rash
2%
Tender nail bed
100%
80%
60%
40%
20%
0%
Study treatment Arm
Palbociclib + Letrozole or + Fulvestrant
Trial Design
12Treatment groups
Experimental Treatment
Group I: Dose Expansion: Cohort X: GDC-9545 Dose 3Experimental Treatment1 Intervention
GDC-9545 will be administered at a pre-defined dose level (Dose 3) to postmenopausal participants currently receiving clinical benefit with GDC-0927 or GDC-0810 on Studies GO29656 (NCT02316509) or GO29642 (NCT01823835), respectively, upon completion of their studies.
Group II: Dose Expansion: Cohort C2: GDC-9545 Dose 2 + PalbociclibExperimental Treatment2 Interventions
GDC-9545 will be administered to postmenopausal participants at a pre-defined dose level (Dose 2), in combination with the label-recommended dose of palbociclib.
Group III: Dose Expansion: Cohort C1: GDC-9545 Dose 2 +/- PalbociclibExperimental Treatment2 Interventions
GDC-9545 will be administered to postmenopausal participants at a pre-defined dose level (Dose 2) as a single agent for 14 days, followed by treatment with either GDC-9545 (Dose 2) plus palbociclib or GDC-9545 (Dose 2) alone for the duration of the study, as determined by the investigator.
Group IV: Dose Expansion: Cohort B2: GDC-9545 + Palbociclib + LHRHExperimental Treatment3 Interventions
GDC-9545 will be administered to pre- or perimenopausal participants, at a dose that is less than or equal to the MTD/MAD, in combination with the label-recommended dose of palbociclib and an approved LHRH agonist.
Group V: Dose Expansion: Cohort B1: GDC-9545 + PalbociclibExperimental Treatment2 Interventions
GDC-9545 will be administered to postmenopausal participants, at a dose that is less than or equal to the MTD/MAD, in combination with the label-recommended dose of palbociclib.
Group VI: Dose Expansion: Cohort A5: GDC-9545 Dose 3Experimental Treatment1 Intervention
GDC-9545 will be administered to postmenopausal participants as a single-agent at a dose that is less than or equal to the MTD/MAD (Dose 3).
Group VII: Dose Expansion: Cohort A4: GDC-9545 Dose 2 + LHRHExperimental Treatment2 Interventions
GDC-9545 will be administered to pre- or perimenopausal participants at a dose that is less than or equal to the MTD/MAD (Dose 2) in combination with an LHRH agonist.
Group VIII: Dose Expansion: Cohort A3: GDC-9545 Dose 2Experimental Treatment1 Intervention
GDC-9545 will be administered to postmenopausal participants as a single-agent at a dose that is less than or equal to the MTD/MAD (Dose 2).
Group IX: Dose Expansion: Cohort A2: GDC-9545 Dose 1 + LHRHExperimental Treatment2 Interventions
GDC-9545 will be administered to pre- or perimenopausal participants at a dose that is less than or equal to the MTD/MAD (Dose 1) in combination with an approved LHRH agonist.
Group X: Dose Expansion: Cohort A1: GDC-9545 Dose 1Experimental Treatment1 Intervention
GDC-9545 will be administered to postmenopausal participants as a single-agent at a dose that is less than or equal to the MTD/MAD (Dose 1).
Group XI: Dose Escalation: GDC-9545Experimental Treatment1 Intervention
During dose escalation, postmenopausal participants will be assigned sequentially to escalating doses of GDC-9545, up to the maximum tolerated dose (MTD) or maximum administered dose (MAD).
Group XII: Dose Escalation: Cohort B0: GDC-9545 + PalbociclibExperimental Treatment2 Interventions
GDC-9545 will be administered to postmenopausal participants, at a dose lower than the MTD or MAD determined in single-agent dose escalation, in combination with the label-recommended dose of palbociclib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LHRH Agonist
2013
Completed Phase 2
~130
Palbociclib
2017
Completed Phase 3
~3710
Find a Location
Who is running the clinical trial?
Genentech, Inc.Lead Sponsor
1,538 Previous Clinical Trials
567,572 Total Patients Enrolled
96 Trials studying Breast Cancer
23,037 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,265 Total Patients Enrolled
137 Trials studying Breast Cancer
71,915 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 4 weeks.I have not had radiation therapy in the last 2 weeks.You have a history of significant heart rhythm problems or a past heart attack.I haven't had any cancer other than early-stage uterine, skin (non-melanoma), or cervical (in situ) in the last 3 years.I am HIV positive.I have an active inflammatory bowel condition or have had major GI surgery.I cannot or will not take pills or capsules.I have cancer that can be measured or seen in my bones.My breast cancer has returned or spread and cannot be removed or cured with surgery or radiation.My breast cancer is HER2-negative.I have brain metastases that are either untreated, causing symptoms, or need treatment for symptoms.I am currently taking warfarin or phenytoin.My doctor can safely take samples of my cancer before and during treatment.I am fully active or can carry out light work.All side effects from my previous treatments have mostly gone away.My organs are working well.I am not on any cancer treatments for advanced disease, except if I'm in Cohort X receiving GDC-0810 or GDC-0927.My heart's electrical activity, measured twice, shows a specific irregularity.My advanced cancer does not respond to or cannot tolerate standard treatments.I have had 2 or fewer treatments for advanced breast cancer.It's been over 2 months since I last used tamoxifen and over 6 months since I last used fulvestrant.I have gone through menopause.I am currently taking medication that can affect my heart's rhythm.I have a history or risk of irregular heartbeats due to heart conditions or family history.My tumor is estrogen receptor positive.You are expected to live for at least 12 more weeks.It has been over 2 weeks since my last cancer treatment.I have not been treated with CDK4/6 inhibitors before.I have a serious liver condition, such as hepatitis or cirrhosis.My breast cancer is ER-positive/HER2-negative and has worsened despite hormone therapy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many geographical areas is this research taking place in?
"Currently, 6 medical facilities are running this clinical trial; these sites can be found in New york, Aurora and Nashville as well as other cities. To reduce the amount of travelling needed to take part in the study, it is best to pick a location close by."
Answered by AI
Are there any other research endeavors that have incorporated GDC-9545 into their protocols?
"Currently, 16 trials are in Phase 3 and 133 research initiatives concerning GDC-9545 remain underway. The majority of the studies for GDC-9545 center around Burgas, New jersey, though there is a total of 6577 sites running related clinical experiments."
Answered by AI
What has GDC-9545 been indicated to ameliorate?
"GDC-9545 is an efficient treatment for breast cancer and other neoplasms, postmenopausal symptoms, as well as advanced directives."
Answered by AI
Has GDC-9545 gained regulatory clearance from the US Food and Drug Administration?
"The safety score for GDC-9545 is estimated to be 1 as per the evaluation conducted by our Power team. This assessment takes into consideration that this clinical trial is in its initial phase, with limited data available on both efficacy and security."
Answered by AI
What is the current number of participants in this research project?
"At this juncture, this clinical trial is not enrolling any new patients. The investigation was first posted on 27 November 2017 and the most recent update to the entry happened 28 October 2022. If you are in search of other trials, there are currently 2600 studies for breast cancer recruitment and 133 seeking participants for GDC-9545."
Answered by AI
Is the research team looking for participants at this time?
"This particular clinical trial is currently not recruiting participants. Initially posted on November 27th 2017, the latest update to this study was recorded on October 28th 2022. For those exploring other studies, 2600 trials are actively seeking patients with breast cancer and 133 studies for GDC-9545 are accepting new enrollees at present."
Answered by AI
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