Health TrialsbyHealthPanel

Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort

ConditionsInvasive Mammary CarcinomaMetastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSonya Reid

About this trial

This is an open-label, multicenter, two-arm Phase II clinical trial that will evaluate the impact of 2nd line chemotherapy (i.e. capecitabine) on survival in patients with non-Luminal A hormone receptor-positive (HR+) metastatic breast cancer (MBC)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed and dated written informed consent.

Subjects ≥ 18 years of age.

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

ER (>/=1%) and/or PR (>/= 1%) by IHC and HER2 negative (by IHC or FISH)

Disqualifiers

Prior chemotherapy in the metastatic setting

Previous malignant disease other than breast cancer within the last 2 years with associated competing risk, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of study drugs AND additional therapy not required while receiving study treatment).

Persisting symptoms related to prior therapy that has not reduced to Grade 1 [National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) version 5.0]; however, menopausal symptoms, alopecia, and sensory neuropathy Grade ≤ 2 is acceptable

Pregnant or breastfeeding females.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Capecitabine

    Drug

    2000 mg taken by mouth twice daily for 7 days on, 7 days off

  • Endocrine-therapy

    Other intervention

    Endocrine therapy administered

  • MammoPrint ® and BluePrint assays

    Other intervention

    Archival tissue will be analyzed using the MammoPrint ® and BluePrint assays

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Physician's Choice of Endocrine-based Therapy_Non-Luminal A subtypesActive comparator 2 interventions
Group B: Capecitabine_Non-Luminal A subtypesExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression free survival

Time frame
Up to 3 years

Secondary outcomes

1

Overall survival at 2 years

Time frame
Up to 2 years
2

Overall survival at 5 years

Time frame
Up to 5 years
3

Overall survival at 10 years

Time frame
Up to 10 years
4

Clinical Benefit Rate

Percentage of patients without disease progression at 6 months

Time frame
Approximately 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sonya Reid

Lead sponsor

Vanderbilt-Ingram Cancer Center

Sponsor institution

Agendia

Collaborator

Susan G. Komen Breast Cancer Foundation

Collaborator

Source ClinicalTrials.gov
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