The study was stopped early due to increased global access to genomic screening. It is no longer economical to continue with this particular single-gene screening protocol.

This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) . Participants with histologically confirmed, hormone receptor positive, HER-2 negative, metastatic breast cancer (MBC) or metastatic cervical cancer (MCC) are eligible for screening at 6 months intervals, or if disease progression is suspected/confirmed. Blood samples will be collected from eligible participants and ctDNA will be extracted and sequenced at a central laboratory, using a HER2-targeted next generation sequencing (NGS) test. A certified molecular test report will be issued from the central laboratory and provided to the investigators and the study sponsor. Participants who are identified with HER2 mutations by this screening protocol will subsequently have access to an appropriate neratinib treatment protocol, pending medical eligibility.

Inclusion Criteria:

• Women and men who are ≥18 years old at signing of informed consent
• Eastern Cooperative Oncology Group (ECOG) status of 0 to 2
• Provide written informed consent to participate in the study and for circulating tumor DNA screening
• Must be able to provide blood sample(s) for HER2 mutation testing
• Participants with imaging or histologically confirmed, HR-positive, HER2-negative MBC who are presently receiving or have received CDK4/6 inhibitor as a prior therapy in any setting, or participants with imaging or histologically confirmed metastatic cervical cancer
• At least one measurable lesion, as defined by RECIST v1.1

Exclusion Criteria:

• Participants with breast cancer with known HER2-positive or HER2-amplified tumors
• Participants with breast cancer with HR-negative tumors
• Participants who have received HER2-directed TKI
• Participants with previously documented somatic KRAS activating mutation

Participants with histologically-confirmed metastatic breast or metastatic cervical cancer

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In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

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Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.

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