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Alkylating agents

Pre-Surgery Chemotherapy + Trastuzumab for Breast Cancer

N/A

Waitlist Available

Led By Jesus Anampa, MD

Research Sponsored by Albert Einstein College of Medicine

Eligibility Criteria Checklist

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

Must have

Patients with clinically suspicious axillary lymph node involvement must have either aspiration cytology or biopsy prior to beginning therapy

No prior chemotherapy, irradiation, or definitive therapeutic surgery (eg, mastectomy or lumpectomy or axillary dissection) for this malignancy; patients who have had a prior sentinel lymph node biopsy for this malignancy are eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 months

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 20 Other Conditions

Summary

This trial is testing chemotherapy drugs and an antibody before surgery in patients with stage II-III breast cancer to see if it kills more tumor cells. Tissue samples will be collected to study how patients respond to treatment.

Who is the study for?

This trial is for patients with stage IIA-IIIC breast cancer who haven't had prior chemotherapy, radiation, or definitive surgery for the malignancy. They must have documented hormone receptor status and be medically fit for preoperative chemo and surgery. Prior tamoxifen use is allowed if stopped one week before enrollment.

What is being tested?

The study tests pre-surgery chemotherapy using doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and trastuzumab to see how well they kill tumor cells in breast cancer patients. It also involves collecting tissue samples to understand treatment response.

What are the potential side effects?

Chemotherapy drugs may cause side effects like nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts. Trastuzumab can lead to heart problems or allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I have had a biopsy or aspiration of my lymph nodes before starting treatment.

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I haven't had chemo, radiation, or major surgery for my cancer, but a sentinel lymph node biopsy is okay.

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My breast cancer is confirmed and I plan to have surgery after initial treatment.

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The hormone status of my cancer was tested before starting treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in senescence and secondary biomarkers, including TMEM, mena, and 67LR

Secondary study objectives

Changes in quantitative biomarker levels in patients with chemotherapy-responsive and -resistant tumors, including senescence, cell death, TMEM, mena, and 67LR

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Headache

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Stratum C (AC followed by paclitaxel)Experimental Treatment5 Interventions

Patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks. Patients then receive paclitaxel IV over 1 hour weekly for 12 weeks.

Group II: Stratum B (paclitaxel followed by AC)Experimental Treatment5 Interventions

Patients receive paclitaxel, doxorubicin hydrochloride, and cyclophosphamide as in Stratum A.

Group III: Stratum A (HER2-positive disease)Experimental Treatment6 Interventions

Patients receive paclitaxel IV over 1 hour and trastuzumab IV over 30-90 minutes weekly for 12 weeks. Beginning 2-3 weeks after the last dose of paclitaxel, patients receive doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 30-60 minutes every 2 weeks for 8 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

FDA approved

Cyclophosphamide

FDA approved

Paclitaxel

FDA approved

Trastuzumab

FDA approved