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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

Study 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.Check my eligibility
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.See study design
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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My doctor agrees I can undergo chemotherapy and surgery before my main treatment.
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I am willing to sign consent and provide blood samples, and I'm open to optional research biopsies.
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The hormone status of my cancer was tested before starting treatment.
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I've had a mammogram in the last 6 months and possibly an ultrasound or MRI if needed.
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I have or will have metallic clips in my tumor before starting treatment to help with surgery.
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I have stopped taking tamoxifen or similar medications at least a week ago.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in senescence and secondary biomarkers, including TMEM, mena, and 67LR
Secondary outcome measures
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%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Aspartate aminotransferase increased
9%
Musculoskeletal pain
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Insomnia
6%
Transaminases increased
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

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

Find a Location

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
285 Previous Clinical Trials
11,854,510 Total Patients Enrolled
8 Trials studying Breast Cancer
1,342,261 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,603 Previous Clinical Trials
40,913,143 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Jesus Anampa, MDPrincipal InvestigatorAlbert Einstein College of Medicine
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Breast Cancer
20 Patients Enrolled for Breast Cancer

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01897441 — N/A
Breast Cancer Research Study Groups: Stratum C (AC followed by paclitaxel), Stratum B (paclitaxel followed by AC), Stratum A (HER2-positive disease)
Breast Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT01897441 — N/A
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01897441 — N/A

Frequently Asked Questions

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

What is the cap on participants for this medical trial?

"This medical trial is currently not open to participants. It was originally published on June 1st, 2013 and the most recent edit occurred August 11th 2022. If you are looking for other studies, 2293 trials recruiting patients with stage iia breast cancer and 1825 clinical tests searching for Paclitaxel volunteers are available."

Answered by AI

Is this experiment pioneering a new avenue of research?

"Globally, 1825 trials investigating Paclitaxel are in progress across 3709 cities and 82 nations. This therapeutic agent was originally tested by Alfacell back in 1997 when 300 participants were enrolled for a Phase 3 evaluation. Since then, 3138 assessments have been finished."

Answered by AI

Has Paclitaxel been the focus of any previous medical investigations?

"Currently, 1825 studies are being conducted that research Paclitaxel of which 410 have entered Phase 3. Though the majority of these trials occur in Seattle, Washington, there are almost 78 thousand locations involved worldwide."

Answered by AI

To what ailments is Paclitaxel commonly prescribed?

"Paclitaxel has been known to effectively treat a wide range of conditions including cyclophosphamide, kaposi's sarcoma aids related, and leukemia."

Answered by AI

Is enrollment still open for this medical investigation?

"As per data hosted on clinicaltrials.gov, this particular research project is not presently recruiting patients. The trial was first posted in June 2013 and last updated in August 2022; however, there are over four thousand additional trials actively enrolling participants."

Answered by AI
~18 spots leftby Dec 2025