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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
Must not have
Patients must not have > grade 1 peripheral neuropathy of any etiology
Patient must not have a history of any prior (ipsilateral or contralateral) invasive breast cancer
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

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe numbness or pain in my hands or feet.
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I have never had invasive breast cancer before.
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I have not received any treatment for my current breast cancer.
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I do not have any serious health conditions that could interfere with the treatment.
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My breast cancer has not spread to distant parts of my body.
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I am capable of making my own health decisions.
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My breast cancer is not at stage T4 or N3, and it's not inflammatory.

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)
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Recurrence-free survival (RFS)
Secondary study objectives
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
2017
Completed Phase 2
~740
Radiation Therapy
2017
Completed Phase 3
~7250
Nab-paclitaxel
2014
Completed Phase 3
~1950
Docetaxel
1995
Completed Phase 4
~5620
Mastectomy
2017
Completed Phase 2
~11220
Paclitaxel
2011
Completed Phase 4
~5810
Pertuzumab
2014
Completed Phase 3
~7500
Trastuzumab Emtansine
2016
Completed Phase 3
~5730

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
119 Previous Clinical Trials
176,891 Total Patients Enrolled
4 Trials studying Breast Cancer
3,528 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,000,844 Total Patients Enrolled
945 Trials studying Breast Cancer
1,543,964 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
~682 spots leftby Oct 2026
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