Health Trials

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer

ConditionsBreast CancerBreast NeoplasmBreast Cancer FemaleBreast Cancer InvasiveBreast Cancer Stage IIBreast Cancer Stage IIITriple Negative Breast CancerHormone Receptor-positive Breast CancerHER2-positive Breast CancerTriple Negative Breast NeoplasmsEstrogen Receptor-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaylor Breast Care Center

About this trial

The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.

Eligibility criteria

Qualifiers

At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.

Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines).

Tumors must be at least 2 cm by clinical exam or ultrasound

Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.

Disqualifiers

Definitive clinical or radiologic evidence of Stage IV disease

Inflammatory breast cancer

Participants who are pregnant or lactating

History of an excisional biopsy or lumpectomy performed prior to study entry

Trial design

Treatments tested in this trial

  • Paclitaxel
  • Carboplatin
  • Trastuzumab
  • Pertuzumab
  • Doxorubicin
  • Cyclophosphamide
  • Pembrolizumab
  • Pertuzumab/Trastuzumab/Hyaluronidase-zzxf

Treatment groups

185 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Baylor Breast Care Center

Lead sponsor

Source ClinicalTrials.gov