A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Официальное название

A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Обзор

The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer

Вмешательства

• Препарат Zanidatamab
  Administered intravenously (IV)
• Препарат Paclitaxel
  Administered intravenously (IV)
• Препарат Docetaxel
  Administered intravenously (IV)
• Препарат Carboplatin
  Administered intravenously (IV)
• Препарат Trastuzumab
  Administered intravenously (IV)
• Препарат Pertuzumab
  Administered intravenously (IV)

Первичные конечные точки

• Number of participants with pCR [Срок оценки: Up to 8 months]

Вторичные конечные точки (11)

• Number of participants with Pathologic response by Residual Cancer Burden (RCB) classification [Срок оценки: Up to 8 months]
• Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Срок оценки: Up to 23 months]
• Number of Participants Discontinuing Study Treatment Due to TEAEs [Срок оценки: Up to 23 months]
• Number of participants that completed breast conservation surgery (BCS) [Срок оценки: Up to 8 months]
• Event Free Survival (EFS) [Срок оценки: Up to 46 months]
• Overall Survival (OS) [Срок оценки: Up to 46 months]
• Number of participants reporting Symptomatic Adverse Events based on Patient-reported Outcome-Common Terminology Criteria for AEs (PRO-CTCAE) [Срок оценки: Up to 23 months]
• Number of participants reporting Symptomatic Adverse Events based on European Organisation for Research and Treatment of Cancer (EORTC) Item Library [Срок оценки: Up to 23 months]
• Percentage of all treated participants reporting overall side-effect bother on the Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5) [Срок оценки: Up to 23 months]
• Serum Concentrations of Zanidatamab [Срок оценки: Up to 18 months]
• Number of Participants Positive for Anti-drug Antibodies to Zanidatamab [Срок оценки: Up to 18 months]

Критерии участия

Критерии включения

• Has newly diagnosed Stage II or III histologically confirmed invasive breast carcinoma.
• Has histologically confirmed HER2-positive breast cancer
• Has a known hormone receptor (HR) status of the primary tumor
• Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive.
• Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function
• Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 6 weeks prior to randomization.
• Adequate contraceptive precautions
• Participants with known HIV are eligible unless:

• CD4+ T Cell count is less than or equal to 350 microliters (uL)
• Detectable viral load, or
• Receiving protease inhibitors or cobicistat

Критерии исключения

• Has Stage IV (metastatic) breast cancer.
• Has bilateral breast cancer.
• Has a history of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study.
• Has uncontrolled hypertension
• Has significant symptoms from peripheral neuropathy
• Has an active uncontrolled infection
• Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions.
• Known active hepatitis B or C infection.
• Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible.
• Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer
• Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol
• Receipt of a live vaccine within 4 weeks prior to enrollment
• Has a known hypersensitivity to any components of the study interventions, including chemotherapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 27 центров

• Oncology Institute — Long Beach
• Cancer & Blood Research Center — Los Alamitos
• Rocky Mountain Cancer Centers — Denver
• Holy Cross Hospital — Fort Lauderdale
• The Oncology Institute — Lakeland
• Accellacare of McFarland — Ames
• LSU Health Sciences Center — Shreveport
• New England Cancer Specialists — Scarborough
• … и ещё 19 центров

Испания · 5 центров

• Hospital Clínico San Cecilio — Granada
• Álvaro Cunqueiro Hospital — Vigo
• Hospital Universitario Vall d'Hebron — Barcelona
• Hospital Universitario Clinico San Cecilio, — Granada
• Hosp Beata María Ana de Jesús — Madrid

Италия · 1 центр

• Ospedale San Raffaele — Milan

Идентификаторы

NCT: NCT07102381 · JZP598-208 · 2025-523204-68-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗