A Phase 2 interventional study of Docetaxel and Carboplatin in Triple Negative Breast Neoplasms, sponsored by Washington University School of Medicine. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-07.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment
This is a single arm open label phase II study in women with clinical stage 2 or 3 triple negative breast cancer to assess the anti-tumor activity (in terms of pathologic complete response rate) of neoadjuvant docetaxel in combination with carboplatin. Patient derived xenografts will also be developed simultaneously for the purposes of genoproteomic analysis.
Please note that Baylor College of Medicine (BCM) has a parallel study the same as this study. Baylor is expected to enroll approximately 19 participants that have complied with the inclusion and exclusion criteria for this study (excluded participants from BCM will include male participants or participants with inflammatory breast cancer). The investigators will pool participants and data from the BCM study and the study at Washington University School of Medicine. Pooling the data will potentially improve statistical power.
1,163 studies on the registry are indexed under Triple Negative Breast Neoplasms; 447 are open to participants now.
This study's enrollment of 148 is above the median of 61 across 1,001 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Washington University School of Medicine is the lead sponsor of 1,795 studies on the registry; 271 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 216 (65%) have results posted.
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Normal bone marrow and organ function as defined below:
Exclusion Criteria:
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion. A total of 6 cycles will be given.
Drug: Docetaxel · Drug: Carboplatin · Procedure: FDG-PET/MR
Docetaxel will be administered intravenously at a dose of 75mg/m2 over 60 minutes on Day 1 of each 21-day cycle. Carboplatin AUC 6 will be administered intravenously over 30 minutes on Day 1 of each 21-day cycle immediately following docetaxel infusion.
Drug: Docetaxel · Drug: Carboplatin · Procedure: FDG-PET/MR
Also known as: Docefrez®, Taxotere®
Also known as: Paraplatin, Paraplatin-AQ
* Prior to initialization of Cycle 1 and completion of cycle 1 (preferably on cycle 2 day 1) * This is not optional for final 30 participants enrolled on the study
Pathological Complete Response (pCR) Rate
-A patient is considered to not to have a pCR if any of the following are true: * There is histologic evidence of invasive tumor cells in the surgical breast specimen or the axillary lymph nodes. * The patient has discontinued neoadjuvant treatment early due to refusal, toxicity, or radiographic evidence of progression and then goes straight to surgery where there is histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes * The patient has discontinued neoadjuvant treatment early due to refusal, toxicity or radiographic evidence of progression and then receives alternative treatment. * The patient discontinues study treatment, refuses surgery, or is unable to undergo surgery due to a co-morbid condition. Thus, any patient who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pCR.
Time frame: At the time of surgery (surgery will take place 3-5 weeks after completion of treatment and estimated treatment length is 18 weeks)
| Milestone | Washington University: Neoadjuvant Docetaxel and Carboplatin | Baylor: Neoadjuvant Docetaxel and Carboplatin |
|---|---|---|
| Started | 123 | 25 |
| Completed | 106 | 19 |
| Not completed | 17 | 6 |
| Withdrew: Adverse event | 7 | 2 |
| Withdrew: Went to alternative treatment | 4 | 0 |
| Withdrew: Withdrawal by subject | 2 | 1 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Not eligible | 1 | 0 |
| Withdrew: Did not receive carboplatin in cycle 6 | 1 | 3 |
-A patient is considered to not to have a pCR if any of the following are true: * There is histologic evidence of invasive tumor cells in the surgical breast specimen or the axillary lymph nodes. * The patient has discontinued neoadjuvant treatment early due to refusal, toxicity, or radiographic evidence of progression and then goes straight to surgery where there is histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes * The patient has discontinued neoadjuvant treatment early due to refusal, toxicity or radiographic evidence of progression and then receives alternative treatment. * The patient discontinues study treatment, refuses surgery, or is unable to undergo surgery due to a co-morbid condition. Thus, any patient who does not receive alternative treatment prior to surgery and has no histologic evidence of invasive tumor cells in the surgical breast specimen and the axillary lymph nodes is considered to have a pCR.
| Participants | Washington University: Neoadjuvant Docetaxel and Carboplatin | Baylor: Neoadjuvant Docetaxel and Carboplatin |
|---|---|---|
| Pathological Complete Response (pCR) Rate | 47 | 11 |
Collected over Adverse events were collected from start of treatment through 30 days after completion of treatment. Treatment could continue for a total of 6 cycles and each cycle is 21 days in length. All-cause mortality was followed from start of treatment through completion of follow-up. Follow-up for survival is for 5 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Washington University: Neoadjuvant Docetaxel and Carboplatin | 9/123 (7.3%) | 21/123 (17.1%) | 123/123 (100%) |
| Baylor: Neoadjuvant Docetaxel and Carboplatin | 3/25 (12%) | 3/25 (12%) | 16/25 (64%) |
| Event | Washington University: Neoadjuvant Docetaxel and Carboplatin | Baylor: Neoadjuvant Docetaxel and Carboplatin |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 6/123 | 1/25 |
| ColitisGastrointestinal disorders | 3/123 | 1/25 |
| VertigoEar and labyrinth disorders | 0/123 | 1/25 |
| DiarrheaGastrointestinal disorders | 3/123 | 0/25 |
| Neutrophil count decreasedInvestigations | 3/123 | 0/25 |
| AnemiaBlood and lymphatic system disorders | 2/123 | 0/25 |
| Abdominal painGastrointestinal disorders | 2/123 | 0/25 |
| NauseaGastrointestinal disorders | 2/123 | 0/25 |
| VomitingGastrointestinal disorders | 2/123 | 0/25 |
| PainGeneral disorders | 2/123 | 0/25 |
| Event | Washington University: Neoadjuvant Docetaxel and Carboplatin | Baylor: Neoadjuvant Docetaxel and Carboplatin |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 108/123 | 4/25 |
| AlopeciaSkin and subcutaneous tissue disorders | 101/123 | 0/25 |
| FatigueGeneral disorders | 95/123 | 1/25 |
| Platelet count decreasedInvestigations | 82/123 | 2/25 |
| NauseaGastrointestinal disorders | 81/123 | 0/25 |
| Peripheral sensory neuropathyNervous system disorders | 75/123 | 2/25 |
| Lymphocyte count decreasedInvestigations | 68/123 | 2/25 |
| ConstipationGastrointestinal disorders | 64/123 | 0/25 |
| DiarrheaGastrointestinal disorders | 63/123 | 4/25 |
| AnorexiaMetabolism and nutrition disorders | 60/123 | 1/25 |
| Age, Continuous(years) | Washington University: Neoadjuvant Docetaxel and Carboplatin | Baylor: Neoadjuvant Docetaxel and Carboplatin | Total |
|---|---|---|---|
| Median | 53 (25 to 77) | 57 (29 to 71) | 53 (25 to 77) |
| Sex: Female, Male(Participants) | Washington University: Neoadjuvant Docetaxel and Carboplatin | Baylor: Neoadjuvant Docetaxel and Carboplatin | Total |
|---|---|---|---|
| Female | 123 | 25 | 148 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Washington University: Neoadjuvant Docetaxel and Carboplatin | Baylor: Neoadjuvant Docetaxel and Carboplatin | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 9 | 9 |
| Not Hispanic or Latino | 123 | 16 | 139 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Washington University: Neoadjuvant Docetaxel and Carboplatin | Baylor: Neoadjuvant Docetaxel and Carboplatin | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 32 | 1 | 33 |
| White | 89 | 22 | 111 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Washington University: Neoadjuvant Docetaxel and Carboplatin | Baylor: Neoadjuvant Docetaxel and Carboplatin | Total |
|---|---|---|---|
| United States | 123 | 25 | 148 |
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Ran from Jul 2014 to primary completion in Nov 2021, 88 months.
Results were first posted in Nov 2022, 11 months after primary completion.
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Studies of the drugs tested here: Docetaxel · Carboplatin
Triple Negative Breast Neoplasms →
Washington University School of Medicine →