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AKT Inhibitor/MEK Inhibitor/ATR Inhibitor

Combination Therapy for Triple Negative Breast Cancer

Phase 2
Recruiting
Led By Zahi Mitri, MD, MS
Research Sponsored by OHSU Knight Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Metastatic TNBC with specific hormone receptor and HER2 status
Participants with or without germline BRCA mutated TNBC
Must not have
Participants unable to swallow orally administered medication and participants with gastrointestinal disorders likely to interfere with absorption of the study medication
Concomitant use of specified medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up death (any cause) up to 1 year post treatment
Awards & highlights

Summary

This trial is testing 3 different combinations of drugs or 1 drug by itself to see if it can effectively treat patients with a certain type of breast cancer.

Who is the study for?
This trial is for adults with metastatic triple negative breast cancer who haven't been treated with PARP inhibitors like olaparib. They must be able to consent, have a life expectancy of at least 16 weeks, and agree to biopsies and contraception if applicable. Exclusions include certain medication use, other cancers unless cured over 5 years ago, CNS metastases, major surgery recently, or conditions affecting drug absorption.
What is being tested?
The study tests the effectiveness of olaparib combined with durvalumab (a monoclonal antibody), selumetinib (MEK inhibitor), capivasertib (AKT inhibitor) or ceralasertib alone (ATR inhibitor) in treating metastatic triple negative breast cancer. The goal is to see if these combinations can stop tumor growth by blocking enzymes needed for cell growth.
What are the potential side effects?
Potential side effects may include nausea, fatigue, blood count changes from olaparib; immune-related reactions from durvalumab; skin rash or heart issues from selumetinib; hyperglycemia or rash from capivasertib; and anemia or fatigue from ceralasertib. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer has spread, is triple-negative, and lacks certain hormone receptors and HER2.
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My triple-negative breast cancer may or may not have a BRCA mutation.
Select...
I am 18 years old or older.
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I agree to have a tumor biopsy after 2 weeks of starting olaparib treatment.
Select...
I have never been treated with PARP inhibitors like olaparib.
Select...
I have a tumor that can be measured and biopsied.
Select...
I have received treatments for breast cancer that has spread.
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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot swallow pills or have a stomach condition that affects medication absorption.
Select...
I am currently taking certain medications.
Select...
My tumor shows high levels of androgen receptor.
Select...
I have been diagnosed with MDS/AML or show signs of these conditions.
Select...
I have active brain metastases or carcinomatous meningitis.
Select...
I am currently taking hormone therapy for a condition that is not cancer.
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I am not currently receiving any cancer treatments.
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I am currently on antibiotics for an infection.
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I have had a bone marrow or double cord blood transplant.
Select...
I have active hepatitis B or C.
Select...
My condition is critical due to organ failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~death (any cause) up to 1 year post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and death (any cause) up to 1 year post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Clinical benefit rate (CBR)
Duration of response (DOR)
Incidence of grade 3+ acute toxicity
+2 more
Other study objectives
Change in QOL as measured by EORTC QLQBR23
Change in quality of life (QOL) as measured by European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

Side effects data

From 2023 Phase 3 trial • 154 Patients • NCT02184195
49%
Nausea
47%
Fatigue
38%
Diarrhoea
29%
Abdominal pain
29%
Anaemia
28%
Constipation
27%
Decreased appetite
27%
Back pain
26%
Vomiting
21%
Arthralgia
19%
Pyrexia
18%
Asthenia
13%
Rash
13%
Nasopharyngitis
11%
Alanine aminotransferase increased
11%
Dyspnoea
10%
Neuropathy peripheral
10%
Cough
10%
Abdominal pain upper
10%
Dyspepsia
10%
Anxiety
10%
Pruritus
9%
Aspartate aminotransferase increased
9%
Hyperglycaemia
9%
Dizziness
9%
Thrombocytopenia
9%
Oedema peripheral
9%
Pain in extremity
9%
Insomnia
9%
Stomatitis
9%
Dry mouth
9%
Headache
9%
Neutropenia
8%
Blood creatinine increased
8%
Weight decreased
7%
Dysgeusia
7%
Blood alkaline phosphatase increased
7%
Neutrophil count decreased
7%
Muscle spasms
7%
Influenza
7%
Influenza like illness
7%
Myalgia
7%
Peripheral sensory neuropathy
7%
Gamma-glutamyltransferase increased
6%
Hypertension
6%
Platelet count decreased
6%
Depression
6%
Lymphopenia
6%
Gastrooesophageal reflux disease
6%
Abdominal distension
5%
Musculoskeletal pain
3%
Flank pain
2%
Cholangitis
2%
Flatulence
2%
Paraesthesia
1%
General physical health deterioration
1%
Bladder papilloma
1%
Pneumonia pneumococcal
1%
Abdominal infection
1%
Bartholinitis
1%
Pneumonia
1%
Cerebrovascular accident
1%
Pneumothorax
1%
Gastric varices haemorrhage
1%
Large intestinal obstruction
1%
Cholecystitis
1%
Anastomotic haemorrhage
1%
Device occlusion
1%
Stent malfunction
1%
Bronchiolitis
1%
Empyema
1%
Syncope
1%
Incisional hernia
1%
Device dislocation
1%
Obstruction gastric
1%
Cardiac failure
1%
Vascular stenosis
1%
Pleural effusion
1%
Incarcerated inguinal hernia
1%
Urinary tract infection
1%
Hypothyroidism
1%
Transient ischaemic attack
1%
Infusion related reaction
1%
Duodenal perforation
1%
Melaena
1%
Bile duct obstruction
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Olaparib 300 mg Twice Daily (bd)
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm IV (ceralasertib)Experimental Treatment3 Interventions
Patients receive ceralasertib PO BID on days 1-14 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit from treatment may, at the investigator's discretion and in the absence of disease progression or unacceptable toxicity, continue on therapy beyond the planned 13 cycles.
Group II: Arm III (olaparib, capivasertib)Experimental Treatment4 Interventions
Patients receive olaparib PO BID on days 1-28 of each cycle and capivasertib PO BID 4 days on and 3 days off of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit from treatment may, at the investigator's discretion and in the absence of disease progression or unacceptable toxicity, continue on therapy beyond the planned 13 cycles.
Group III: Arm II (olaparib, selumetinib)Experimental Treatment4 Interventions
Patients receive olaparib PO BID on days 1-28 of each cycle and selumetinib PO BID on days 1-28 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit from treatment may, at the investigator's discretion and in the absence of disease progression or unacceptable toxicity, continue on therapy beyond the planned 13 cycles.
Group IV: Arm I (olaparib, durvalumab)Experimental Treatment4 Interventions
Patients receive olaparib PO BID on days 1-28 of each cycle and durvalumab intravenously (IV) over 1 hour on day 1 of each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit from treatment may, at the investigator's discretion and in the absence of disease progression or unacceptable toxicity, continue on therapy beyond the planned 13 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capivasertib
2021
Completed Phase 1
~130
Olaparib
2007
Completed Phase 4
~2190
Biopsy
2014
Completed Phase 4
~1090
Ceralasertib
2017
Completed Phase 1
~40
Selumetinib
2010
Completed Phase 2
~2080
Durvalumab
2017
Completed Phase 2
~3840

Find a Location

Who is running the clinical trial?

OHSU Knight Cancer InstituteLead Sponsor
234 Previous Clinical Trials
2,088,495 Total Patients Enrolled
14 Trials studying Breast Cancer
2,317 Patients Enrolled for Breast Cancer
AstraZenecaIndustry Sponsor
4,352 Previous Clinical Trials
288,646,677 Total Patients Enrolled
176 Trials studying Breast Cancer
1,245,578 Patients Enrolled for Breast Cancer
Oregon Health and Science UniversityOTHER
994 Previous Clinical Trials
7,386,816 Total Patients Enrolled
5 Trials studying Breast Cancer
396 Patients Enrolled for Breast Cancer

Media Library

Capivasertib (AKT Inhibitor/MEK Inhibitor/ATR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03801369 — Phase 2
Breast Cancer Research Study Groups: Arm I (olaparib, durvalumab), Arm III (olaparib, capivasertib), Arm II (olaparib, selumetinib), Arm IV (ceralasertib)
Breast Cancer Clinical Trial 2023: Capivasertib Highlights & Side Effects. Trial Name: NCT03801369 — Phase 2
Capivasertib (AKT Inhibitor/MEK Inhibitor/ATR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03801369 — Phase 2
~24 spots leftby Dec 2025
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