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 range20 Years

SexFEMALE

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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 …

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

Number of Participants With Inability to Complete Treatment, Defined as a Patient That Requires a Lower Dose of Therapy (Defined as Dose Lowered by 50%), or a Postponement of Scheduled Treatment of Longer Than 28 Days, or Discontinuation for Any Reason

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