Paclitaxel for Breast Cancer

Albert Einstein College of Medicine, Bronx, NY
Breast Cancer+5 More ConditionsPaclitaxel - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Stage IIB Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIA Breast Cancer
  • Breast Cancer, Stage IIIB
  • Breast Cancer Stage IIIc
  • Breast Cancer Stage IV

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Baseline to 6 months

Baseline to 6 months
Changes in senescence and secondary biomarkers, including TMEM, mena, and 67LR
Week 8
Changes in quantitative biomarker levels in patients with chemotherapy-responsive and -resistant tumors, including senescence, cell death, TMEM, mena, and 67LR

Trial Safety

Phase-Based Safety

1 of 3

Side Effects for

Trastuzumab
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
9%Aspartate aminotransferase increased
9%Headache
9%Musculoskeletal pain
9%Chest discomfort
9%Rash
9%Pigmentation disorder
9%Nausea
9%Bone marrow failure
9%Anaemia
6%Transaminases increased
6%Insomnia
6%Nasopharyngitis
6%Paronychia
6%Flushing
6%Face oedema
6%Constipation
6%Mouth ulceration
6%Thrombocytopenia
3%Cataract
3%Infection
3%Upper respiratory tract infection
3%Completed suicide
This histogram enumerates side effects from a completed 2014 Phase 4 trial (NCT01301729) in the Trastuzumab ARM group. Side effects include: Leukopenia with 59%, Neutropenia with 56%, Hypoaesthesia with 34%, Agranulocytosis with 31%, Alopecia with 22%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new 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

3 Treatment Groups

Stratum A (HER2-positive disease)
1 of 3
Stratum B (paclitaxel followed by AC)
1 of 3
Stratum C (AC followed by paclitaxel)
1 of 3

Experimental Treatment

132 Total Participants · 3 Treatment Groups

Primary Treatment: Paclitaxel · No Placebo Group · N/A

Stratum A (HER2-positive disease)Experimental Group · 6 Interventions: Cyclophosphamide, Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Paclitaxel, Trastuzumab, Doxorubicin Hydrochloride · Intervention Types: Drug, Other, Other, Drug, Biological, Drug
Stratum B (paclitaxel followed by AC)Experimental Group · 5 Interventions: Cyclophosphamide, Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Paclitaxel, Doxorubicin Hydrochloride · Intervention Types: Drug, Other, Other, Drug, Drug
Stratum C (AC followed by paclitaxel)Experimental Group · 5 Interventions: Cyclophosphamide, Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis, Paclitaxel, Doxorubicin Hydrochloride · Intervention Types: Drug, Other, Other, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Paclitaxel
FDA approved
Trastuzumab
FDA approved
Doxorubicin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 6 months

Who is running the clinical trial?

Albert Einstein College of MedicineLead Sponsor
270 Previous Clinical Trials
1,839,535 Total Patients Enrolled
8 Trials studying Breast Cancer
1,342,261 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,272 Previous Clinical Trials
41,230,596 Total Patients Enrolled
931 Trials studying Breast Cancer
1,537,986 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

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.