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New treatment option for Breast Cancer
Official title A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
ClinicalTrials.gov ID: NCT07054190
What this study is testing
What is Inavolisib?
Inavolisib is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as GDC-0077, RO7113755.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging...
- Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
- Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
- Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
You likely can't join if
- Stage IV (metastatic) BC
- Inflammatory BC (cT4d)
- Bilateral invasive BC
- History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the...
- Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the...
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
See the full eligibility criteria
- Histologically confirmed operable or inoperable invasive Stage II-III BC according to American Joint Committee on Cancer (AJCC) TNM staging classification
- Candidate for neoadjuvant treatment and considered appropriate for endocrine combination therapy
- Willingness to undergo breast surgery (mastectomy or breast-conserving surgery) after neoadjuvant treatment (unless inoperable)
- Documented ER-positive tumor in accordance with current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines
- Documented HER2-negative tumor in accordance with current ASCO/CAP guidelines
- Documented Ki-67 score \>=5% as per local assessment
- Confirmed PIK3CA mutation
- Stage IV (metastatic) BC
- Inflammatory BC (cT4d)
- Bilateral invasive BC
- History of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for treatment or radiation therapy to the ipsilateral breast
- Previous systemic or local treatment for the primary BC currently under investigation (including excisional biopsy or any other surgery of the primary tumor and/or axillary lymph nodes, including sentinel lymph node...
- Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Orange, California, United States
- Germantown, Tennessee, United States
- Morgantown, West Virginia, United States
- Buenos Aires, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
- Goiânia, Goiás, Brazil
- Recife, Pernambuco, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- São Paulo, São Paulo, Brazil
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Berlin, Germany
- Dresden, Germany
- Essen, Germany
- Heidelberg, Germany
- Paderborn, Germany
- Schwerin, Germany
- Seoul, South Korea
- Barcelona, Spain
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Orange, California, United States; Germantown, Tennessee, United States; Morgantown, West Virginia, United States; Buenos Aires, Argentina; Ciudad Autonoma Buenos Aires, Argentina and 18 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.