A Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC)

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• Breast Neoplasms 12,544

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 102 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study arms

• Experimental
  Trastuzumab

  Participants with HER2+ eBC who completed the first 6 cycles of trastuzumab IV infusion as part of the (neo) adjuvant treatment will be included to continue to receive 12 cycles of trastuzumab to complete a total of 18 cycles of trastuzumab. Participants will receive trastuzumab IV infusion at initial loading dose of 8 mg/kg BW for q3w regimen as a part of neo adjuvant treatment before entering in the study and then recommended maintenance dose of 6 mg/kg BW q3w for the first 3 cycles (cycles 7-9) in hospital followed by SC administration of trastuzumab at a fixed dose of 600 mg q3w for next 3 cycles (Cycles 10-12) at hospital and SC administration of trastuzumab at a fixed dose of 600 mg q3w at home for the next 6 cycles (Cycles 13-18) (Each cycle=21 days).

  Drug: Trastuzumab

• No intervention
  Health Care Professionals

  Health Care Professionals (HCPs) included for polling purposes. HCPs were not enrolled in the study.

Interventions

• DrugTrastuzumab

  Trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w; Trastuzumab 600 mg q3w SC injection will be administered as per the schedule specified in the arm.

  Also known as: Herceptin

Primary outcomes

1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

   An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs included both serious and non- serious AEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. An emergent AE was defined as occurring within 35 days after last treatment administration.

   Time frame: Up to 45 months

Secondary outcomes

1. Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 1 (PSQ1): In-Hospital

   PSQ1 is a quality of care questionnaire containing 14 questions each of Sections A and B, with a total of 28 questions categorized on the opinion of participants about the clinicians, opinion of participants about the other staff and other questions. Responses to questions with section A (except question 11) were categorized to "not at all", "to a small extent", "to a moderate extent", "to a large extent", "to a very large extent", "Not applicable" and "missing". Responses to questions with section B were categorized to "Not important", "a little important", "important", "very important", "of utmost importance", "not applicable" and "missing". Responses to question 11 with section A were categorized to "Yes, but not long", "yes, quite long", "yes, much long" and "missing". Participant experience with the treatment provided during the in-hospital part of the study was evaluated with PSQ1 questionnaire completed by the participant prior to the first dose of trastuzumab SC at home.

   Time frame: Prior (0 hour) to first trastuzumab SC administration at Cycle 13 (cycle length =21 days)

2. Number of Participants With Modalities Assessed Using Patient Satisfaction Questionnaire 2 (PSQ2): At Home

   PSQ2 is a quality of care questionnaire containing 13 questions each of Sections A and B, with a total of 26 questions categorized on the opinion of participants about the clinicians, opinion of participant about the other staff and other questions. Responses to questions with section A were categorized to "Not at all", "To a small extent", "to a moderate extent", "to a large extent", "to a very large extent", "Not applicable" and "missing". Responses to questions with section B were categorized to "Not important", "a little important", "important", "very important", "of utmost importance", "not applicable" and "missing". Participant experience with the treatment provided during the at-home part of the study was evaluated with the PSQ2 questionnaire completed by the participant prior to the fifth dose of trastuzumab SC at home.

   Time frame: Prior (0 hour) to fifth trastuzumab SC administration at Cycle 17 (cycle length=21 days)

3. Participant-reported Severity of Symptoms as Assessed by Monroe Dunaway Anderson Symptom Inventory (MDASI) Questionnaire

   MDASI questionnaire is used to rate the severity of 13 core items (pain, fatigue, nausea, vomiting, disturbed sleep, distress, shortness of breath, memory difficulties, lack of appetite, drowsiness, dry mouth, sadness, numbness or tingling). Participants were asked to rate the severity of each symptom "at its worst" using 0-10 numerical rating scales with 0 = "not present" and 10 = "as bad as you can imagine." Total score was summed and ranged from 0 to 130, with lower scores indicating better outcome.

   Time frame: Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)

4. Participant-reported Interference of Symptoms With Life as Assessed by MDASI Questionnaire

   MDASI questionnaire is used to rate the interference of symptoms. The measure includes 6 symptom interference items which ask how much all symptoms, interfere with domains (general activity, mood, work, relations with others, walking, and enjoyment of life). Each items were rated on a 0-10 scale (0 = "did not interfere"; 10 = "interfered completely"). Lower scores indicating better outcome. Total score was summed and ranged from 0 to 50, with lower scores indicating better outcome.

   Time frame: Prior (0 hours) to Cycles 7, 10, 13, 16 (Each cycle=21 days)

5. Number of Participants With Modalities Assessed Using Patient Experience Questionnaires (PEX) - Part 1:In-Hospital

   PEX-Part 1 questionnaire contains 25 items to assess participant's experience on use of trastuzumab at hospital.1.Place of treatment? 2.Was it same place as for chemotherapy? 3.How long did it take to travel there? 4.How easy was travel? 5.Company required for travelling? 6.Was travelling cost a problem? 7.Considering all these,was travelling for treatment overall a problem? 8.How helpful were nursing/medical staff? 9.How pleasant was place of study? 10.How was IV treatment given? 11.If Venous Access Device(VAD),what was it? 12.Did hospital staff have difficulty inserting cannula? 13.Time for cannulation? 14.How painful was IV? 15.How much time to access port/line usually take? 16.How painful was it? 17.Time for IV sessions? 18.Anxiety level while IV treatment? 19.How would you describe IV sessions? 20.Did hospital staff have difficulty giving SC? 21.Time for SC? 22.How painful was SC? 23.Time for SC sessions? 24.Anxiety level while SC treatment? 25.How would you describe SC sessions?

   Time frame: Prior (0 hours) to Cycle 12 (cycle length=21 days)

6. Number of Participants With Modalities Assessed Using PEX - Part 2: At Home

   PEX - Part 2 questionnaire contains 6 items to assess the participant's experience on the use of trastuzumab SC vials at home.Participants answered the following questions: 1. Did the nursing staff ever have any difficulty giving the trastuzumab injection SC? 2. How many minutes did the injection (it) usually take? 3. How painful was this usually? 4. How long did the SC sessions usually last from arrival until departure of the nurse? 5. How anxious did having the SC treatment make you feel? 6. In general how would you describe these SC treatment sessions at home?

   Time frame: 1 month after end of treatment (up to 10 months)

7. Number of Health Care Professionals With Modalities Assessed Using Health Care Professional Questionnaire (HCPEX-1)

   HCPEX-1 questionnaire is used to assess health care professional's overall satisfaction and perceived time savings with trastuzumab SC vial in the hospital. The HCPEX-1 questionnaire (19 questions) was completed by the health care professionals administering the trastuzumab IV and SC in the hospital after at least 3 participants had completed the in-hospital part of the study.

   Time frame: Prior (0 hours) to Cycle 12 (cycle length=21 days)

8. Disease-Free Survival (DFS) as Assessed by Routine Clinical, Radiological and Laboratory Criteria

   DFS was defined as time from first study drug administration (i.e. Day 1 of Cycle 7) to local, regional or distant recurrence, contralateral breast cancer or death from any cause (whichever occurred first). Diagnosis of breast cancer relapse was made based on routine clinical, radiological and laboratory criteria. Acceptable methods of confirmation of recurrence included radiology, computerized tomography (CT) scan, brain scan, ultrasound, or cytology, as per local practice. In case of uncertainly, disease relapse was to be confirmed by histological or cytological examination of a suspicious lesion, if possible.

   Time frame: From start of treatment up to 45 months

Baseline characteristics

Publications

• Denys H, Martinez-Mena CL, Martens MT, D'Hondt RG, Graas ML, Evron E, Fried G, Ben-Baruch NE, Vulsteke C, Van Steenberghe MM. Safety and tolerability of subcutaneous trastuzumab at home administration, results of the phase IIIb open-label BELIS study in HER2-positive early breast cancer. Breast Cancer Res Treat. 2020 May;181(1):97-105. doi: 10.1007/s10549-020-05604-7. Epub 2020 Apr 2. PubMed 32240454 ↗

Study documents

• Protocol and statistical analysis plan · Dec 11, 2015

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