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A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administrationin Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer (ProHer)
EU CTIS ID: 2023-506380-33-00
What this study is testing
To evaluate patient preference of pertuzumab and trastuzumab (PH) fixed-dose combination (FDC) for subcutaneous (SC) administration in the home setting during the cross-over period of the adjuvant phase of the study
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Female and male participants with stage II-IIIC early or locally advanced/inflammatory HER2+ breast cancer
- Primary tumor > 2 cm in diameter, or node-positive disease
- HER2+ breast cancer confirmed by a local laboratory prior to study enrollment
- Hormone receptor status of the primary tumor determined by local assessment following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and updates
- Adequate wound healing after breast cancer surgery per investigator’s assessment to allow initiation of study treatment within ≤ 9 weeks of last systemic neoadjuvant therapy
You likely can't join if
- Stage IV breast cancer
- History of concurrent or previously treated non-breast malignancies except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years
- Participants who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their International Normalized Ratio (INR)
- Inadequate bone marrow function defined by any of: - Participants who have an absolute neutrophil count (ANC) < 1.5 x 109/L - Platelet count < 100 x 109/L - Hemoglobin < 9 g/dL
- Participants who have received any previous systemic therapy (including chemotherapy, immunotherapy, HER2-targeted agents, endocrine therapy [selective estrogen receptor modulators, aromatase inhibitors], and antitumor vaccines for treatment or prevention of breast cancer, or previous chest irradiation radiation therapy for the treatment of cancer
- Participants who have a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) if they have received any systemic therapy for its treatment or radiation therapy to the ipsi- or contralateral breast cancer. Participants are allowed to enter the studyif treated with surgery alone
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Chile
- Turkey
- Argentina
- Costa Rica
- Singapore
- Peru
- South Africa
- Brazil
- Canada
- Mexico
- Bosnia and Herzegovina
- Kenya
- India
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 all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Chile; Turkey; Argentina; Costa Rica; Singapore and 8 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 EU CTIS; the study team decides eligibility.