Phase 2 Trial of Neoadjuvant Weekly Carboplatin Plus Paclitaxel in Triple Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04083963|
Recruitment Status : Recruiting
First Posted : September 10, 2019
Last Update Posted : March 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Drug: Carboplatin Drug: Paclitaxel Drug: Doxorubicin Drug: Cyclophosphamide||Phase 2|
This is a single arm, Phase 2, open label, study to evaluate the safety and efficacy of weekly carboplatin in combination with standard neoadjuvant chemotherapy in subjects with previously untreated triple negative breast cancers who are candidates for potentially curative surgery.
Subjects will receive carboplatin (Area Under the Curve (AUC) 2 mg/mL/min) + paclitaxel (80 mg/m2) Carboplantin plus Paclitaxel (CbP) followed by doxorubicin and cyclophosphamide (AC). All subjects will receive CbP on Day 1 of 12 weekly cycles (Visits CbP1 - CbP12) via infusion during Chemotherapy Segment 1 as indicated in the Study Schema. Dose interruptions and dose modifications are allowed based upon tolerability and may extend Chemotherapy Segment 1 duration to a maximum of 16 weeks. Beginning with Chemotherapy Segment 2 all subjects will receive doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) on Day 1 of four 14-day cycles (Visits AC1 - AC4). For subjects who experience toxicities due to carboplatin, paclitaxel, doxorubicin or cyclophosphamide, the appropriate dose modifications or dosing delays should be managed according to Section 11.2. Dose modifications may result in the total duration of therapy being greater than the planned 24 weeks. The objective of this study is to determine efficacy and tolerability of low dose, weekly carboplatin in combination with weekly paclitaxel followed by standard doxorubicin/cyclophosphamide as neoadjuvant therapy for triple-negative breast cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Carboplatin plus paclitaxel followed by doxorubicin and cyclophosphamide|
|Masking:||None (Open Label)|
|Official Title:||BRE-01: Phase 2 Trial of Neoadjuvant Weekly Carboplatin Plus Paclitaxel Followed by Doxorubicin and Cyclophosphamide in Triple Negative Breast Cancer|
|Actual Study Start Date :||August 5, 2019|
|Estimated Primary Completion Date :||February 5, 2022|
|Estimated Study Completion Date :||February 5, 2022|
Low dose weekly carboplatin in combination with standard neoadjuvant chemotherapy
Low dose weekly carboplatin (AUC 2) will be combined with weekly paclitaxel for 12 weeks.
Other Name: Paraplatin
Paclitaxel will be given weekly along with carboplatin for 12 weeks.
Other Name: Taxol
Dose dense doxorubicin will be administered in combination with cyclophosphamide for 4 cycles after weekly carboplatin/paclitaxel.
Other Name: Adriamycin
Does dense cyclophosphamide will be in combination with doxorubicin for 4 cycles after weekly carboplatin/paclitaxel.
Other Name: Cytoxan
- Pathological complete response (pCR) rate [ Time Frame: 30 months ]Defined as the absence of residual invasive carcinoma in the resected breast specimen and ipsilateral axillary lymph nodes following completion of neoadjuvant therapy (i.e., ypT0/Tis, ypN0 per the American joint Committee on Cancer staging system) in all subjects completing at least 1 cycle of study treatment (modified intent-to-treat population)
- Pathologic complete response rate in subjects completing protocol therapy. [ Time Frame: 30 months ]Pathologic complete response rate Defined as the absence of residual invasive carcinoma in the resected breast specimen and ipsilateral axillary lymph nodes following completion of neoadjuvant therapy (i.e., ypT0/Tis, ypN0 per the American joint Committee on Cancer staging system) will be determined in the sub-group of subjects completing at least 75% of planned treatment cycles.
- Residual Cancer Burden [ Time Frame: 30 months ]The Residual Cancer Burden (RCB) class will be estimated from routine pathologic sections of the resected primary breast tumor and the regional lymph nodes after the completion of neoadjuvant therapy. RCB class 0 represents pCR, and class I represents minimal residual invasive disease. Class II and III represent significant residual disease. We will report the rate of achieving RCB class 0/1 vs. II/III.
- Event-free survival (EFS) [ Time Frame: 30 months ]Time from enrollment to any of the following: failure to undergo potentially curative surgery; onset of local, regional, or distant invasive recurrence of breast cancer following curative surgery; second primary invasive cancer in the breast or in another organ; or death from any cause.
- Invasive disease-free survival (iDFS) [ Time Frame: 30 months ]Time from enrollment to any of the following: development of invasive cancer in the ipsilateral breast or regional nodes, contralateral breast or regional nodes, distant metastases, or death from any cause
- Distant disease-free survival (DDFS) [ Time Frame: 30 months ]Time from enrollment to documentation of distant metastases or death from any cause
- Overall survival (OS) [ Time Frame: 30 months ]Time from enrollment to death from any cause
- Clinical response to neoadjuvant chemotherapy [ Time Frame: 30 months ]Defined as progressive disease, stable disease, partial response and complete response according to RECIST 1.1 criteria in the modified intent-to-treat population and participants completing at least 75% of protocol therapy
- Breast conservation rate [ Time Frame: 30 months ]The percentage of women undergoing adequate partial mastectomy as determined by treating physicians and achieving negative pathological surgical margins (no ink on tumor).
- Treatment tolerability [ Time Frame: 30 months ]Number of cycles delayed, deleted or requiring dose reduction; number of participants who fail to complete all planned courses of protocol therapy; number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
- Quality of life Measurement [ Time Frame: 30 months ]Change in score on the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 quality of life survey. This 30-item survey uses a Likert scale with total scores ranging from 30-126, with increasing scores indicating worse quality of life. We will compare mean baseline scores to scores at the end of protocol therapy, and 3 and 12 months after completing all protocol therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04083963
|Contact: Kent Hoskins, M.D.||email@example.com|
|Contact: Annette R Kinsella, RNfirstname.lastname@example.org|
|Principal Investigator:||Kent Hoskins, M.D.||University of Illinois at Chicago|