Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response

NCT02280252 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 06-209
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The need to understand LABC is especially compelling in populations and countries with limited resources, where breast cancer incidence is relatively low, but mortality is comparably high. In these settings access to appropriate cancer care is characteristically limited or often plainly nonexistent. In contrast to economically developed nations, where on average fewer than 20% of women present with breast cancer at advanced stages, LABC and metastatic disease are the most common stages at presentation in 50% or more women in Latin America, Asia and Africa.

Conditions

Breast Cancer

Keywords

Locally-advanced Breast Cancer; LABC; breast cancer; breast; cancer; metastasis; metastatic; tumor; radiation; radiation therapy; radiotherapy; paclitaxel

Outcome Measures

Primary Outcomes (1)

• Test the Clinical Effectiveness of Concurrent Paclitaxel and Radiation in a Multiethnic Cohort

  Test the effectiveness of concurrent paclitaxel and radiation in a prospective multiethnic cohort of patients with newly diagnosed stage 2B-3C breast cancer treated at three international academic centers under uniform conditions. Local recurrence, regional recurrence and overall survival will be measured

  4.5 years

Secondary Outcomes (3)

• Measure the Pathological Response Rate of Concurrent Paclitaxel-radiation

  4.5 years

• Perform Molecular Biology and Genomic Studies of Obtained Core Biopsies to Identify Biomarkers for Predisposition to Breast Cancer

  4.5 years

• Patient Demographics

  4.5 years

Study Arms (1)

Concurrent Paclitaxel and RT

EXPERIMENTAL

Patients will be administered pre-operatively over 12 weeks either: 1. Paclitaxel, 30mg/m\^2 twice per week, intravenously over 1 hour on a Monday/Thursday or Tuesday/Friday schedule 2. Abraxane, 30mg/m\^2 twice per week, intravenously administered over 30 minutes, on a Monday/Thursday or Tuesday/Friday schedule Patients will concurrently receive 6 weeks of radiation therapy, weeks 2-7: Patients will receive a total dose to the breast, axilla and supraclavicular area of 45 Gy at 1.8 Gy/fraction, +14 Gy to the area of the original palpable tumor at 2 Gy/fraction (32 fractions)

Drug: Paclitaxel; Radiation: Radiation therapy

Interventions

Paclitaxel DRUG

Paclitaxel (including Abraxane), 30 mg/m2 twice per week. Paclitaxel will be given IV over 1 hour, Abraxane® will be administered over 30 min, and administered on a Monday/Thursday or Tuesday/Friday schedule.

Also known as: Abraxane

Concurrent Paclitaxel and RT

Radiation therapy RADIATION

Patients will receive a total dose of 45 Gy to the breast, axilla and supraclavicular area at 1.8 Gy/fraction, +14 Gy to the original palpable tumor at 2 Gy/fraction (total 32 fractions)

Also known as: radiotherapy

Concurrent Paclitaxel and RT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven locally-advanced breast cancer: IIB, IIIA, and IIIB
• Metastatic breast cancer: limited to the subset of patients with intact breast, locally advanced tumor and involved ipsilateral supraclavicular nodes
• Measureable disease required
• Adequate laboratory values:
• Hgb \> 10 ANC \> 1500 Platelets \> 150,000 Creatinine \< 1.5 Liver function \< 3x normal
• Patient ≥ 18 years of age
• Medically and psychologically able to comply with all study requirements
• ECOG performance score 0-1
• CT chest, abdomen, and pelvis performed
• Mammogram or USG performed
• Signed informed consent

You may not qualify if:

• Breast cancer patients with Stage 0, Stage I, or Stage IIA
• Previous XRT or chemotherapy
• Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes
• Pregnancy
• Inflammatory breast cancer
• Patients under treatment (or who will have recently been treated) with anti-neoplastic, immunosuppressive or hormonal medications
• Patients who are found to have a cancer positive for the marker HER-2/neu (applies only to NYU Tisch and Bellevue sites)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Neoplasm Metastasis

Interventions

Paclitaxel; Albumin-Bound Paclitaxel; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Therapeutics

Results Point of Contact

• Title: Dr. Nelly Huppert
• Organization: NYU Langone Health

Nelly.Huppert@nyulangone.org

(212) 731-5003

Study Officials

• Nelly Huppert, M.D.

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2014
• First Posted: October 31, 2014
• Study Start: March 1, 2005
• Primary Completion: December 20, 2018
• Study Completion: December 20, 2018
• Last Updated: November 23, 2020
• Results First Posted: November 23, 2020

Record last verified: 2020-11

Locations

US (1)