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A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
- Inflammatory Breast Cancer
- Locally Advanced Breast Cancer
- Breast Cancer HER-2 Positive
- Early Breast Cancer
Trial Status:
Recruiting
This trial runs in
Cities
- Ankara
- Banja Luka
- Barrie
- Buenos Aires
- Ceará
- Ciudad de México
- Edirne
- El Palmar
- Goiás
- İstanbul
- Jaén
- Johannesburg
- La Florida
- Montréal
- Oshawa
- Panagyurishte
- Pleven
- Plovdiv
- Pretoria
- Providencia
- Québec
- Rio Grande do Sul
- Salamanca
- San José
- San Luis Potosí
- Santa Ana
- Seoul
- Singapore
- Sofia
- São Paulo
- Toronto
- Zagreb
- zenica
Trial Identifier:
NCT05415215 2021-002346-33 MO43110
Trial Summary
This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT05415215 , MO43110 , 2021-002346-33
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
1. Why is the ProHer clinical trial needed?
The standard treatment for early or locally advanced human epidermal growth factor receptor
2-positive (HER2+) breast cancer is a combination of drugs called pertuzumab and trastuzumab with chemotherapy. Previous studies in hospital settings have shown that pertuzumab and trastuzumab treatment works equally well when given as an infusion into a vein (intravenous [IV]), which takes a few hours), or when given as an injection under the skin (which takes a few minutes).
This trial will assess whether people with HER2+ breast cancer prefer to receive pertuzumab and trastuzumab injections under the skin at home or in a hospital setting.
2. How does the ProHer clinical trial work?
This clinical trial is open to people who have a health condition called early or locally advanced HER2+ breast cancer. People can take part if they plan to have surgery to remove their tumour.
In this clinical trial, treatment will be given in 2 parts:
In Part 1 (before surgery), participants will be given pertuzumab and trastuzumab every 3 weeks for either 4 or 6 treatment cycles plus chemotherapy in the hospital. A treatment cycle is the treatment and recovery time before the next infusion or injection. Pertuzumab and trastuzumab treatment will be given either as:
● An infusion directly into a vein, or
● An injection under the skin
In Part 2 (after surgery), participants from Part 1 who have no detectable cancer remaining in either the surgically removed breast or lymph nodes tissues, will be given injections under the skin of pertuzumab and trastuzumab every 3 weeks for 2 treatment cycles in the hospital – this is called the ‘run-in’ period. Participants will then be given pertuzumab and trastuzumab as injections under the skin in the ‘cross-over’ period either:
● Every 3 weeks for 3 treatment cycles in the hospital and then every 3 weeks for 3 cycles in their home, or
● Every 3 weeks for 3 treatment cycles in their home and then every 3 weeks for 3 cycles in the hospital
Participants can then choose to receive the rest of their pertuzumab and trastuzumab injections at home or in the hospital until they have been given a total of 18 cycles of treatment – this is called the treatment continuation period.
All treatments will be given by a qualified healthcare professional (a nurse or a doctor) in the hospital or in the home setting; self-injection is NOT allowed.
Participants with cancer cells remaining after surgery will be given a treatment called trastuzumab emtansine. This will be as an infusion into a vein every 3 weeks for 14 cycles in the hospital.
The total time in this clinical trial will be around 1.5‒2 years. Participants are free to stop trial treatment and will not lose access to regular care.
3. What are the main endpoints of the ProHer clinical trial?
The main clinical trial endpoint (the main result that is measured in the trial) is the number of participants who preferred treatment at home rather than in the hospital, based on the responses provided in a Patient Preference Questionnaire.
Other clinical trial endpoints include:
● The number of healthcare professionals who found it more convenient and quicker to give treatment as an injection under the skin than as an infusion
● The number of participants who have undetectable cancer following treatment in Part 1 and surgery (pathological complete response)
● Changes in participants’ health-related quality-of-life, which is measured using a questionnaire
● The number and type of side effects that participants experience
4. Who can take part in this clinical trial?
People can take part in this trial if they have been diagnosed with early or locally advanced HER2+ breast cancer, are 18 years of age or older, are able to have injections in their thigh, and agree to having surgery to remove any remaining breast cancer and axillary (underarm) lymph node cancer after treatment in Part 1.
People may not be able to take part in this trial if they have advanced breast cancer (that has spread to other parts of the body), certain medical conditions or have previously received certain treatments. Women cannot take part in this trial if they are pregnant or breastfeeding or are planning to become pregnant soon after the clinical trial.
5. What treatment will participants be given in this clinical trial?
Everyone who joins this clinical trial will, prior to surgery, be split into one of two groups randomly (by chance) and given, in the hospital, either:
● Pertuzumab and trastuzumab infusions into a vein plus chemotherapy, or
● Pertuzumab and trastuzumab injections under the skin plus chemotherapy
Following surgery, participants who have no detectable cancer will be given pertuzumab and trastuzumab as an injection under the skin every 3 weeks for 2 treatment cycles and they will then be split into two groups randomly and be given either:
● Pertuzumab and trastuzumab injections under the skin for 3 treatment cycles in the hospital and then for 3 cycles in their home, or
● Pertuzumab and trastuzumab injections under the skin for 3 treatment cycles in their home and then for 3 cycles in the hospital.
Depending on their preference, participants will receive their remaining treatment either at home or in the hospital, until a total of 18 cycles (in Parts 1 and 2) of pertuzumab and trastuzumab treatment have been given.
Following surgery, participants who still have detectable cancer will be given trastuzumab emtansine as an infusion into a vein in the hospital every 3 weeks for 14 treatment cycles. If they have unmanageable side effects to trastuzumab emtansine, the clinical trial doctor may decide to treat participants with pertuzumab and trastuzumab as an injection under the skin until they have been given a total of 14 treatment cycles (with any treatment) following surgery. Alternatively, the clinical trial doctor may decide to give a different treatment approved to be used where the participant lives, and the participant will stop being part of the trial.
This is an open-label clinical trial, which means everyone involved, including the participants and the doctors, know which clinical trial drug is being used.
6. Are there any risks or benefits in taking part in this clinical trial?
Most trials involve some risks to the participant, although it may not be greater than the risks related to routine medical care or the natural progression of the health condition. Potential participants will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. These will all be described in an informed consent document (a document that provides people with the information they need to make a decision to volunteer for a clinical trial). A potential participant should also discuss these with members of the research team and with their usual healthcare provider. Anyone interested in taking part in a clinical trial should know as much as possible about the trial and feel comfortable asking the research team any questions about the trial.
Risks associated with the clinical trial drugs
Participants may have side effects (an unwanted effect of a drug or medical treatment) from the drugs used in this clinical trial. Side effects can be mild to severe and even life-threatening and can vary from person to person.
Pertuzumab, trastuzumab and trastuzumab emtansine
Potential participants will be told about the known side effects of pertuzumab, trastuzumab and trastuzumab emtansine, and where relevant, also potential side effects based on human and laboratory studies or knowledge of similar drugs.
Pertuzumab and trastuzumab will be given as an infusion into a vein or as an injection under the skin. Trastuzumab emtansine will be given as an infusion into a vein. Participants will be told about any known side effects of infusions or injections.
Potential benefits associated with the ProHer clinical trial
Participants' health may or may not improve from participation in the clinical trial, but the information that is collected may help other people who have a similar medical condition in the future.
For more information about this clinical trial see the For Expert tab on the specific ForPatients page or follow this link to ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT05415215
Trial Summary
This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT05415215 , MO43110 , 2021-002346-33
Trial Identifier
Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC), Pertuzumab IV, Trastuzumab IV, Trastuzumab Emtansine, Investigator's Choice of Chemotherapy, Surgery, Radiotherapy
Treatments
Early Breast Cancer, Locally Advanced Breast Cancer, Inflammatory Breast Cancer
Condition
Official Title
A Phase IIIB, Multinational, Multicenter, Randomized, Open-Label Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Intact skin at planned site of subcutaneous (SC) injections
- Left ventricular ejection fraction (LVEF) greater than or equal to (≥)55% by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
- Negative human immunodeficiency virus (HIV) test at screening
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb); Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test
- Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening
- For female participants of childbearing potential: agreement to remain abstinent or use contraception and agree to refrain from donating eggs during the treatment period and for 7 months after the final dose of the study treatment
- For male participants: agreement to remain abstinent or use a condom, and agree to refrain from donating sperm during the treatment period and for 7 months after the final dose of study treatment
Disease-specific Inclusion Criteria:
- Female and male participants with stage II-IIIC early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer
- Primary tumor >2 centimetres (cm) in diameter, or node-positive disease
- HER2+ breast cancer confirmed by a local laboratory prior to study enrollment. HER2+ status will be determined based on pretreatment breast biopsy material and defined as 3+ by Immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2018 and updates (Wolff et al. Arch Pathol Lab Med 2018)
- 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 (Allison et al. J Clin Oncol 2020)
- Agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy, including the axillary nodes
- Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for local confirmation of HER2 and hormone receptor status following current ASCO/CAP guidelines
Inclusion Criteria for Treatment with Adjuvant PH FDC SC:
- Completed the neoadjuvant phase of this study and underwent surgery, and achieved pathologic complete response (pCR), defined as eradication of invasive disease in the breast and axilla according to the current American Joint Committee on Cancer (AJCC) staging system classification, and using the resected specimen by the local pathologist on the basis of guidelines to be provided in a pathology manual
- Adequate wound healing after breast cancer surgery per investigator's assessment to allow initiation of study treatment within less than or equal to (≤)9 weeks of last systemic neoadjuvant therapy
Exclusion Criteria
- Stage IV (metastatic) 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 are pregnant or breastfeeding or intending to become pregnant during the study or within 7 months after the final dose of study treatments
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Active, unresolved infections at screening requiring treatment
- 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)
- Serious cardiac illness or medical conditions
- History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
- Inadequate bone marrow function
- Impaired liver function
- Renal function with creatinine clearance <50 mL/min using the Cockroft-Gault formula and serum creatinine >1.5x upper limit of normal (ULN)
- Major surgical procedure unrelated to breast cancer within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment
- Current severe, uncontrolled systemic disease that may interfere with planned treatment
- Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study
- Treatment with a live vaccine (e.g., FluMist) in the 30 days prior to initiation of study treatment, or anticipation of need for such a vaccine during treatment or within 90 days after the final dose of study treatment
- Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis
- Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins or a history of severe allergic or immunological reactions, e.g., difficult to control asthma
- Current chronic daily treatment with corticosteroids
- Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol
Cancer-specific Exclusion Criteria for Neoadjuvant Phase:
- Participants who have received any previous systemic therapy for treatment or prevention of breast cancer, or previous chest irradiation 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 with high-risk for breast cancer who have received chemopreventive drugs in the past
- Participants with multicentric breast cancer, unless all tumors are HER2+
- Participants with bilateral breast cancer
- Participants who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes
- Axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy
- Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy
Exclusion Criterion for Treatment with Adjuvant Trastuzumab Emtansine (Arm E):
- Current Grade ≥3 peripheral neuropathy (according to the NCI CTCAE v5.0)
For the latest version of this information please go to www.forpatients.roche.com