CompletedPhase 2

Cyclophosphamide, Paclitaxel, and Trastuzumab in Treating Stage I-II HER2/Neu Positive Breast Cancer After Surgery

United States20 participantsStarted 2015-12-11

Plain-language summary

This phase II trial studies the side effects and how well cyclophosphamide, paclitaxel, and trastuzumab work when given after surgery in treating patients with stage I-II human epidermal growth factor receptor (HER2/neu) positive breast cancer (confined to the breast or the breast and lymph nodes under the arm). Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab, may interfere with the ability of tumor cells to grow and spread. Giving cyclophosphamide, paclitaxel, and trastuzumab after surgery may help prevent the cancer from coming back.

Who can participate

Age range

20 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Histologically confirmed newly diagnosed stage I-II HER2/neu positive breast cancer * Women of reproductive potential must be non-pregnant and non-nursing and must agree to employ an effective barrier method of birth control throughout the study and for up to 6 months following treatment * Women of child-bearing potential must have a negative pregnancy test within 7 days of initiating study (no childbearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and/or both ovaries) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Within 30 days prior to enrollment: Absolute neutrophil count greater than or equal to 1,500/mcl * Within 30 days prior to enrollment: Platelet count equal to or greater than 150,000/mcl * Within 30 days prior to enrollment: Hemoglobin \> 11 gm/dl * Within 30 days prior to enrollment: Alkaline phosphatase equal or less than 1.5 times the upper limit of normal (ULN) * Within 30 days prior to enrollment: Total bilirubin equal to or less than 1.5 times the ULN * Within 30 days prior to enrollment: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no greater than 1.5 times the ULN * Within 30 days prior to enrollment: Creatinine less than 1.5 times the ULN * Able to give informed consent * All included subjects must have normal cardiac function as defined by an ejection fraction of \> 50% by echocardiogram * Able to return …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number Participants With Neutropenia, Graded According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version (v)4.03

Timeframe: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).

Number of Participants With Paclitaxel-related Neuropathy, Graded According to the NCI CTCAE v4.03

Timeframe: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).

Number of Participants With Cardiotoxicity Grade 3/4 Cardiotoxicity, Graded According to the NCI CTCAE v4.03

Timeframe: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).

Number of Participants With Grade 3/4 Nausea/Vomiting, Graded According to the NCI CTCAE v4.03

Timeframe: From initiation of study treatment through completion of therapy and up to 3 months after the final dose of study treatment (including trastuzumab).

Number of Participants With Recurrence Free Survival (RFS)

Timeframe: First date of therapy until the first notation of clinical progression, relapse or death from any cause, assessed at 2 years

Trial details

NCT IDNCT02654119

SponsorUniversity of Nebraska

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-08

Results submitted2026-02-04

View on ClinicalTrials.gov More HER2 Positive Breast Carcinoma trials