A Prospective, Open-label Explorative Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases

Plain English Summary

Study of SHR-A1811 in HER2-expression Advanced Breast Cancer With Brain Metastases is a Phase 2 clinical trial sponsored by Henan Cancer Hospital studying Metastatic Breast Cancer. This study tests a new drug called SHR-A1811 for advanced breast cancer that has spread to the brain. It is for patients with HER2-positive or HER2-low advanced breast cancer that has spread to the brain and has not been treated locally. Participants will receive SHR-A1811 intravenously, and may also receive other treatments like Pyrotinib, Bevacizumab, or Adebelizumab. Alternative treatments might include local therapies for brain metastases or other systemic treatments depending on prior therapies. The trial aims to enroll 150 participants.

Official Summary

This study aimed to evaluate the use of SHR-A1811 in HER2-expression Advanced Breast Cancer patients with brain metastases.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with confirmed HER2-positive or HER2-low advanced breast cancer that has spread to the brain. Patients must have at least one measurable brain tumor that has not been treated locally and have not had radiation to the brain. Patients should have adequate organ function and a life expectancy of at least 6 months. Individuals with leptomeningeal involvement, uncontrolled symptomatic brain metastases, or those who have previously received specific antibody-drug conjugates (like trastuzumab deruxtecan) may not be eligible. This trial is studying Metastatic Breast Cancer, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures how well the drug shrinks brain tumors, indicating its potential to control cancer spread in the brain. The specific primary outcome measures are: CNS-ORR by investigator (2 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical need for new treatments for advanced breast cancer that has spread to the brain, a common and challenging complication. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Metastatic Breast Cancer, where improved treatment options are needed.

Investor Insight

This trial explores a novel drug for a difficult-to-treat cancer subset, potentially opening a new therapeutic option in a competitive market for breast cancer treatments. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if SHR-A1811 is a suitable option for you, considering your specific cancer and treatment history. Be prepared for regular intravenous infusions of the study drug and potential oral medications. You will undergo regular scans and tests to monitor your cancer and overall health throughout the study. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NON_RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 150 participants

Interventions

• DRUG: SHR-A1811 — SHR-A1811: intravenous
• DRUG: Pyrotinib — Pyrotinib: oral
• DRUG: Bevacizumab — Bevacizumab: intravenous
• DRUG: Adebelizumab — Adebelizumab: intravenous

Primary Outcomes

• CNS-ORR by investigator (2 months)

Secondary Outcomes

• ORR by investigator using RECIST Guideline (Version 1.1) (2 months)
• PFS (up to 1.5 years)
• Adverse events (up to 1.5 years)

Full Eligibility Criteria

Inclusion Criteria:

1. Females and males ≥18 yrs old;
2. Pathologically confirmed HER2-positive or HER2-low advanced breast cancer;
3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
4. Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
5. More than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. Patients with HER2-Low disease must not have systemic treatment for brain metastases.
6. Prior HER2-target treatment, endocrine therapy and chemotherapy was allowed;
7. Life expectancy is not less than 6 months.
8. Adequate function of major organs.

Exclusion Criteria:

1. Leptomeningeal involvement;
2. CNS complications requiring emergency neurosurgical intervention (e.g. excision, shunt tube placement);or uncontrolled symptomatic brain metastases;
3. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor;
4. Patients who had progressed on previous HER2 tyrosine kinase inhibitor therapy were excluded from Arm 2, and those who had progressed on previous bevacizumab therapy were excluded from Arm 3 and Arm 5 ,and Arm 6 excludes patients who have progressed on prior PD-1 or PD-L1 therapy;
5. No concurrent antitumor therapy for metastatic cancer other than the study treatment;
6. Antitumor radiotherapy, chemotherapy, surgery, targeted therapy, or immunotherapy within 2 weeks or endocrine therapy within 1 week prior to enrolment;
7. Participated in other drug clinical trials within 4 weeks before admission;
8. History of clinically significant lung disease；
9. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
10. According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
11. Any other conditions that researchers believe that patients are unsuitable for this study.

Trial Locations

• Henan Cancer Hospital, Zhengzhou, Henan, China

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Metastatic Breast Cancer
• HER2-Positive Breast Cancer
• HER2-Low Breast Cancer
• Brain Metastases
• Oncology
• Cancer Therapy
• Targeted Therapy
• Antibody-Drug Conjugates
• Clinical Trials

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