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Chemotherapy Reduction After Surgery for Breast Cancer

Phase 2

Recruiting

Led By Nadine M Tung

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

Patients must have AJCC 8th Edition stage II or IIIa according to anatomic staging table at diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 week after cycle 4 (all patients) and/or up to cycle 13 post-surgery (arm a only) (each cycle is 21 days)

Awards & highlights

Study Summary

This trial is studying how well paclitaxel, trastuzumab, and pertuzumab work in eliminating chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery.

Who is the study for?

This trial is for HER2-positive stage II-IIIa breast cancer patients who've had pre-surgery chemo and targeted therapy with no remaining cancer. They must have proper organ function, no history of invasive breast cancer except certain conditions, not be pregnant or breastfeeding, willing to use contraception, and free from serious medical conditions that could affect study participation.Check my eligibility

What is being tested?

The trial tests if paclitaxel combined with trastuzumab and pertuzumab can eliminate the need for further chemotherapy after surgery in patients without remaining cancer post-pre-op treatment. These drugs aim to stop tumor growth by killing cells or blocking growth signals.See study design

What are the potential side effects?

Potential side effects include allergic reactions to medication components, fatigue, nerve damage (neuropathy), blood count changes increasing infection risk, liver function alterations, heart problems due to drug toxicity affecting muscle pumping efficiency.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My hepatitis B virus is undetectable with treatment.

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My cancer was stage II or IIIa when first diagnosed.

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My cancer has not spread to distant parts of my body or affected my lymph nodes severely.

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I do not have severe numbness or pain in my hands or feet.

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My breast cancer's hormone receptor status is known, and it may be positive or negative.

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I have had or am willing to have imaging and a biopsy if needed for suspicious lymph nodes in my armpit.

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My heart pumps blood effectively, with an ejection fraction over 50%.

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My breast cancer is HER2-positive, confirmed by specific tests.

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I am fully active or have some restrictions but can still carry out light work.

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I had certain skin, cervical, or thyroid cancers treated within the last 5 years and no other cancers.

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I had hepatitis C but am now cured, or I am being treated with an undetectable viral load.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 week after cycle 4 (all patients) and/or up to cycle 13 post-surgery (arm a only) (each cycle is 21 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 week after cycle 4 (all patients) and/or up to cycle 13 post-surgery (arm a only) (each cycle is 21 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 week after cycle 4 (all patients) and/or up to cycle 13 post-surgery (arm a only) (each cycle is 21 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Recurrence-free survival (RFS)

Secondary outcome measures

Distant disease-free survival (DDFS)

Distant relapse-free survival (DRFS)

Event-free survival (EFS)

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B (residual invasive disease after surgery)Experimental Treatment8 Interventions

PRE-OPERATIVE/NEOADJUVANT THERAPY: Patients receive either paclitaxel or nab-paclitaxel IV on days 1, 8 and 15, or docetaxel IV on day 1 at the discretion of the treating oncologist. Patients also receive trastuzumab IV on day 1 or days 1, 8, and 15, and pertuzumab IV on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Within 42 days after last dose of neoadjuvant therapy, patients undergo standard of care lumpectomy and/or mastectomy. POST-OPERATIVE/ADJUVANT THERAPY: Patients with remaining tumor after surgery receive standard of care trastuzumab emtansine for 14 doses in the absence of disease progression or unacceptable toxicity. Patients may also receive additional standard of care chemotherapy, as well as hormone therapy if appropriate.

Group II: Arm A (pCR after surgery)Experimental Treatment8 Interventions

PRE-OPERATIVE/NEOADJUVANT THERAPY: Patients receive either paclitaxel or nab-paclitaxel IV on days 1, 8 and 15, or docetaxel IV on day 1 at the discretion of the treating oncologist. Patients also receive trastuzumab IV on day 1 or days 1, 8, and 15, and pertuzumab IV on day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Within 42 days after last dose of neoadjuvant therapy, patients undergo standard of care lumpectomy and/or mastectomy. POST-OPERATIVE.ADJUVANT THERAPY: Patients with pCR after surgery receive trastuzumab and pertuzumab IV on day 1. Treatment repeats every 21 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients may also undergo standard of care radiation therapy and receive hormone therapy if appropriate.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

2014

Completed Phase 4

~5190

Lumpectomy

2008

N/A

~670

Radiation Therapy

2017

Completed Phase 3

~7250

Nab-paclitaxel

2014

Completed Phase 3

~2030

Docetaxel

1995

Completed Phase 4

~5620

Mastectomy

2017

N/A

~11160

Paclitaxel

2011

Completed Phase 4

~5380

Pertuzumab

2014

Completed Phase 3

~7500

Trastuzumab Emtansine

2016

Completed Phase 3

~5630

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

174,766 Total Patients Enrolled

4 Trials studying Breast Cancer

3,528 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,923,749 Total Patients Enrolled

940 Trials studying Breast Cancer

1,543,360 Patients Enrolled for Breast Cancer

Nadine M TungPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Radiation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04266249 — Phase 2

Breast Cancer Research Study Groups: Arm A (pCR after surgery), Arm B (residual invasive disease after surgery)

Breast Cancer Clinical Trial 2023: Radiation Therapy Highlights & Side Effects. Trial Name: NCT04266249 — Phase 2

Radiation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04266249 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities still available for this research endeavor?

"The information presented on clinicaltrials.gov indicates that this experiment is still actively looking for participants. It was originally listed in February 11th 2020 and its most recent update occurred on September 16th 2022."

Answered by AI

Could you please provide information about the previous studies conducted in relation to Radiation Therapy?

"First explored at City of Hope Comprehensive Cancer Center in 1997, radiation therapy has seen the completion of 2,329 trials and is currently being studied within 1,251 actively recruiting experiments. Most notably, many of these studies are performed out Novi, Michigan."

Answered by AI

In what instances is Radiation Therapy typically prescribed?

"Radiation Therapy is an accepted intervention for managing hypoalbuminemia, neoplasm metastasis and acute pyelonephritis (APN)."

Answered by AI

How reliable is Radiation Therapy for providing a safe medical outcome?

"Based on the available evidence, our team at Power rated Radiation Therapy's safety a 2. This is due to this being classified as a Phase 2 trial, where there are some data indicating its security but none that prove efficacy."

Answered by AI

How many venues are involved in conducting this trial?

"This medical trial is currently running at Ascension Providence Hospitals - Novi in Michigan, Temple University Hospital in Philadelphia, and Legacy Cancer Institute Medical Oncology and Day Treatment in Vancouver. Additionally, there are over 100 other sites offering this treatment to patients."

Answered by AI

What is the total participant count for this scientific investigation?

"The trial needs 2156 individuals that meet the stated eligibility criteria to take part. Conveniently, there are two locations in which patients can partake; Ascension Providence Hospitals - Novi located in Michigan and Temple University Hospital situated Pennsylvania."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy

2020. "CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04266249.

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