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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Paclitaxel

    Drug

    80 mg/m2 IV administered on Days 1, 8, 15 of each 21-day cycle

  • Carboplatin

    Drug

    Carboplatin AUC 1.5 IV administered on Days 1, 8, 15 of each 21-day cycle

  • Trastuzumab

    Drug

    Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on Day 1 of each 21-day cycle

  • Pertuzumab

    Drug

    Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on Day 1 of each 21-day cycle

  • Doxorubicin

    Drug

    60 mg/m2 IV administered on Day 1 of each 14-day cycle

  • Cyclophosphamide

    Drug

    600 mg/m2 IV administered on Day 1 of each 14-day cycle

  • Pembrolizumab

    Drug

    Either 200 mg IV administered on Day 1 of Cycles 1-4, or 400 mg IV administered on Day 1 of Cycles 1 and 3 of the paclitaxel/carboplatin regimen. 400 mg on Day 1 of Cycles 1 and 4 of the dose-dense AC regimen.

  • Pertuzumab/Trastuzumab/Hyaluronidase-zzxf

    Drug

    Can be used in place of separate IV formulations of pertuzumab and trastuzumab. 1200 mg pertuzumab/600 mg trastuzumab/30,000 U hyaluronidase administered subcutaneously on Day 1 of the first cycle, followed by a maintenance dose of 600 mg pertuzumab/600 mg trastuzumab/20,000 U hyaluronidase administered subcutaneously every 3 weeks.

Treatment groups

185 Participants
are divided into 4 treatment groups
Group A: Triple Negative Breast Cancer (for tumors > 5 cm)Active comparator 5 interventions
Group B: Triple Negative Breast Cancer (for tumors < 5 cm)Active comparator 3 interventions
Group C: HER2-Positive Breast CancerActive comparator 6 interventions
Group D: Hormone Receptor Positive Breast CancerActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Change in Clinical Tumor Measurement vs. Pathologic Response

Clinical tumor measurements are tumor measurements obtain via imaging (mammogram or ultrasound) or by physical exam. Pathologic response is the amount of tumor remaining at the time of surgery, as determined by the pathologist.

Time frame
Baseline and at surgery (after 20 weeks)

Secondary outcomes

1

Pathologic Complete Response Rate in each Breast Cancer Subtype

A pathologic complete response (pCR) means that there is no residual invasive cancer identified in the tissue removed at surgery. The frequency of pCR will be estimated for each breast cancer subtype (triple negative, hormone receptor positive, and HER2-positive)

Time frame
20 weeks
2

Predictive value of clinical response following 1 cycle of chemotherapy to predict pathologic complete response

This aims to determine whether a 30 percent reduction in tumor size (as measured by physical exam or imaging) following one cycle of chemotherapy can predict whether a patient will have no residual invasive cancer at the time of surgery

Time frame
20 weeks

Other outcomes

1

Change in circulating tumor DNA (ctDNA) levels from baseline to surgery

ctDNA is DNA from a tumor circulating in a patient's bloodstream. The goal of this is to determine whether a decrease in ctDNA levels (as measured from baseline to surgery) correlates to clinical and/or pathologic response

Time frame
20 weeks

Sponsors and contacts

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

Baylor Breast Care Center

Lead sponsor

Source ClinicalTrials.gov
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