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A clinical trial to compare ipatasertib plus atezolizumab and paclitaxel versus a placebo plus different combinations of ipatasertib, atezolizumab and paclitaxel in people with triple-negative breast cancer.
A Study Of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer.
- Cancer
- Breast Cancer
- Triple Negative Breast Cancer
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Completed
This trial runs in
Cities
- A Coruña
- ABD
- Ankara
- Arequipa
- Arkhangelsk
- Atlanta
- Auckland
- Bahia
- Baltimore
- Barcelona
- Barrie
- Basel
- Baton Rouge
- Bellavista
- Bloemfontein
- Bogotá
- Brescia
- Buenos Aires
- cascina-perseghetto
- Castelló de la Plana
- Chang Wat Chiang Mai
- Charleston
- Chernihiv
- Chicago
- Ciudad de México
- Clayton
- Craiova
- Daegu
- Denver
- Detroit
- Dnipro
- Edmonton
- Fort Lauderdale
- Fukushima
- Gent
- George
- Germantown
- Glasgow
- Gliwice
- Goyang-si
- gqeberha
- Grand Island
- Greenville
- Gunma
- Hackensack
- Hasselt
- Helsinki
- Henderson
- Herlev
- Hiroshima
- Hollywood
- Hong Kong Island
- Innsbruck
- İstanbul
- jefferson
- Jerusalem
- Jihomoravský kraj
- Johannesburg
- Kazan
- Kharkiv
- Khon Kaen
- Kifisia
- Kraków
- Krung Thep Maha Nakhon
- Kryvyi Rih
- Kumamoto
- Kuopio
- Kurralta Park
- Kyiv
- La Paz
- La Rioja
- Lebanon
- Lecco
- Lima
- Linz
- Lisboa
- London
- Los Angeles
- Loures
- macquarie-park
- Madrid
- Majadahonda
- Melbourne
- Meldola
- Mendoza
- Mobile
- Monterrey
- Montréal
- Moscow
- Moscow Oblast
- Moskva
- Málaga
- Nagoya
- Napoli
- Nashville
- New Territories
- Nottingham
- Novosibirsk
- Odense
- Odesa
- Okayama
- olomouc-9
- Osaka
- Ottawa
- Padova
- Pembroke Pines
- Pereira
- Portland
- Porto
- Porto Alegre
- Poznań
- Pretoria
- Pune
- Québec
- Rennes
- Río Cuarto
- Saint Albans
- Salzburg
- San Borja
- San Diego
- San Isidro
- San José
- sant-andreu-de-la-barca
- Savannah
- Seoul
- Singapore
- Sofia
- Springdale
- St Leonards
- Stamford
- Stanford
- Subiaco
- Sumy
- Surquillo
- Surrey
- São Paulo
- Taichung City
- Taipei City
- tambon-kho-hong
- Taoyuan City
- Tauranga
- Thessaloniki
- Tuscany
- Udine
- Vaasa
- València
- Waratah
- Warszawa
- Wellington
- Wien
- Winnipeg
- Winston-Salem
- Woolloongabba
- Yokohama
- Ypsilanti
- Zürich
- Łódź
Trial Identifier:
NCT04177108 2019-000810-12 CO41101
Trial Summary
This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04177108, CO41101, 2019-000810-12
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
How does the IPATunity170 clinical trial work?
This clinical trial is recruiting people who have a particular type of breast cancer called triple-negative breast cancer or TNBC. In order to take part, you must have advanced breast cancer that cannot be fully removed with surgery or that has spread to other parts of your body (known as metastatic breast cancer).
The purpose of this clinical trial is to compare the effects, good or bad, of ipatasertib plus atezolizumab and paclitaxel versus placebo plus different combinations of ipatasertib, atezolizumab and paclitaxel in patients with advanced or metastatic TNBC. All patients who join this clinical trial will receive either ipatasertib plus atezolizumab and paclitaxel or ipatasertib plus placebo and paclitaxel or placebo plus paclitaxel or placebo plus atezolizumab and paclitaxel.
How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must have been diagnosed with advanced or metastatic TNBC that cannot be fully removed with surgery.
You cannot join the trial if you are pregnant or breastfeeding.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, he/she may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
While taking part in the clinical trial, both men and women (if you are not currently pregnant but can become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.
What treatment will I be given if I join this clinical trial?
Everyone who joins this clinical trial will be split into 2 groups based on whether their cancer tests positive for PD-L1.
Group 1 – for patients with breast cancer that is not PD-L1-positive
Patients in this group will be split into 3 groups randomly and given either:
- ipatasertib (given as tablets to swallow every day for 3 weeks and then no tablets taken for 1 week) plus atezolizumab (given as an infusion into your vein every 2 weeks) and paclitaxel (given as an infusion into your vein every week for 3 weeks and then not given for 1 week)
- OR ipatasertib (given as tablets to swallow every day for 3 weeks and then no tablets taken for 1 week) plus placebo (given as an infusion into your vein every 2 weeks) and paclitaxel (given as an infusion into your vein every week for 3 weeks and then not given for 1 week)
- OR placebo (given as tablets to swallow every day for 3 weeks and then no tablets taken for 1 week) plus another placebo (given as an infusion into your vein every 2 weeks) and paclitaxel (given as an infusion into your vein every week for 3 weeks and then not given for 1 week)
You will have a 1 in 3 chance of being placed in each group.
OR
Group 2 – for patients with breast cancer that is PD-L1-positive
Patients in this group will be split into 2 groups randomly (like flipping a coin) and given either:
- ipatasertib (given as tablets to swallow every day for 3 weeks and then no tablets taken for 1 week) plus atezolizumab (given as an infusion into your vein every 2 weeks) and paclitaxel (given as an infusion into your vein every week for 3 weeks and then not given for 1 week)
- OR placebo (given as tablets to swallow every day for 3 weeks and then no tablets taken for 1 week) plus atezolizumab (given as an infusion into your vein every 2 weeks) and paclitaxel (given as an infusion into your vein every week for 3 weeks and then not given for 1 week)
You will have an equal chance of being placed in either group.
This is a ‘placebo-controlled’ clinical trial, which means that some patients will be given a medicine with no active ingredients (also known as a ‘placebo’). A placebo is used to show that the doctor or the patients do not sway the results of the clinical trial. All patients in Group 1 will be given at least paclitaxel, and all patients in Group 2 will be given at least atezolizumab and paclitaxel.
Neither you nor your clinical trial doctor can choose or know the group you are in. However, your clinical trial doctor can find out which group you are in, if your safety is at risk.
How often will I be seen in follow-up appointments, and for how long?
You will be given the clinical trial treatment for as long as it can help you. You are free to stop this treatment at any time. While you are being given treatment, you will be monitored to see how you are responding to the treatment and any side effects that you may be having. After being given your last treatment, you will still be seen by the clinical trial doctor within 1 month, and then contacted every 3 months.
What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT04177108?term=CO41101&draw=2&rank=1
Trial-identifier: NCT04177108
Trial Summary
This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT04177108, CO41101, 2019-000810-12
Trial Identifier
Atezolizumab, Ipatasertib, Paclitaxel, Placebo for Atezolizumab, Placebo for Ipatasertib
Treatments
Triple-Negative Breast Cancer
Condition
Official Title
A Phase III, Double-blind, Placebo-controlled, Randomized Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Patients With Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Willingness and ability to complete all study-related assessments, including Participant-Reported Outcome (PRO) assessments, in the investigator's judgement.
- Adequate hematologic and organ function within 14 days before the first study treatment on Day 1 of Cycle 1.
- Life expectancy of at least 6 months.
- Measurable disease according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agreement to refrain from donating eggs.
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm.
- Appropriate candidate for paclitaxel monotherapy if tumor programmed death-ligand 1 (PD-L1) status is unknown or non-positive; appropriate candidate for paclitaxel and atezolizumab if tumor PD-L1 status is positive.
- Histologically documented triple-negative adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent.
Exclusion Criteria
- Inability to comply with study and follow-up procedures.
- History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills.
- Severe infection within 4 weeks prior to initiation of study treatment (including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia) as well as those who have received treatment with therapeutic oral or intravenous (IV) antibiotics within 2 weeks prior to initiation of study treatment.
- Known human immunodeficiency virus (HIV) infection (there must be a negative HIV test at screening).
- Known clinically significant history of liver disease consistent with Child-Pugh Class B or C.
- Current treatment with anti-viral therapy for hepatitis B virus (HBV).
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 of Cycle 1 or anticipation of need for a major surgical procedure during the study.
- Pregnancy or breastfeeding, or intention to become pregnant during the study or within 28 days after the final dose of ipatasertib or (/) placebo, 5 months after the final dose of atezolizumab/placebo, and 6 months after the final dose of paclitaxel whichever occurs later.
- New York Heart Association Class II, III, or IV heart failure, left ventricular ejection fraction less than (<) 50 percent (%), or active ventricular arrhythmia requiring medication.
- Current unstable angina or history of myocardial infarction within 6 months prior to Day 1 of Cycle 1.
- Congenital long QT syndrome or screening QT interval corrected through use Fridericia's formula (QTcF) greater than (>) 480 milliseconds (ms).
- Current treatment with medications used at doses known to cause clinically relevant prolongation of QT/QTc interval.
- History or presence of an abnormal 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).
- Requirement for chronic corticosteroid therapy of > 10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressant agents for a chronic disease.
- Treatment with approved or investigational cancer therapy within 14 days prior to Day 1 of Cycle 1.
- 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 renders the participant at high risk from treatment complications.
- History of or known presence of spinal cord metastases, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments.
- Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases.
- Known germline breast cancer gene (BRCA)1/2 deleterious mutation, unless the participant is not an appropriate candidate for a poly adenosine diphosphate ribose polymerase (PARP)-inhibitor.
- Any previous systemic therapy for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast.
- Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy.
- Participants who have received palliative radiotherapy to peripheral sites (e.g., bone metastases) for pain control and whose last treatment was completed 14 days prior to Day 1 of Cycle 1 may be enrolled in the study if they have recovered from all acute, reversible effects (e.g., to Grade 1 or resolved by enrolment).
- Uncontrolled pleural effusion, pericardial effusion or ascites.
- Uncontrolled tumor-related pain.
- Malignancies other than breast cancer within 5 years prior to Day 1 of Cycle 1, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer.
- Known hypersensitivity or contraindication to any component of the study treatments, including the paclitaxel excipient, macrogolglycerol ricinoleate.
- Grade greater than or equal to (≥) 2 peripheral neuropathy.
- History of Type I or Type II diabetes mellitus requiring insulin.
- Grade ≥ 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia.
- History of or active inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis) or active bowel inflammation (e.g., diverticulitis).
- Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections (pneumocystis pneumonia or cytomegalovirus pneumonia).
- Treatment with strong Cytochrome P450 (CYP)3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug.
- Prior treatment with an Protein kinase B (Akt) inhibitor.
- Active or history of autoimmune disease or immune deficiency.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
- Prior allogeneic stem cell or solid organ transplantation.
- Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment with atezolizumab or within 5 months after the final dose of atezolizumab.
- History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins.
- Known hypersensitivity to Chinese hamster ovary cell products or recombinant human antibodies.
- Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment.
- Treatment with systemic immunosuppressive medication (including, but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the study.
For the latest version of this information please go to www.forpatients.roche.com