DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03716180|
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : December 31, 2018
This research study is studying whether participants and their doctors are willing to determine post-surgery treatment on the basis of response to pre-surgery treatment, and studying blood and tissue collected from participants treated with a combination of drugs as a treatment for breast cancer.
The names study drugs involved in this study are:
- Paclitaxel (also called Taxol)
- Trastuzumab (also called Herceptin)
- Pertuzumab (also called Perjeta)
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Paclitaxel Drug: Trastuzumab Drug: Pertuzumab||Phase 1|
This research study is a Pilot Study, which means investigators are looking at the feasibility of a new approach for deciding the optimal medical treatment for this type of breast cancer. The FDA (the U.S. Food and Drug Administration) has approved paclitaxel, trastuzumab, and pertuzumab as part of a pre-operative treatment option for this disease.
The purpose of this study is to evaluate whether participants and their doctors are willing to accept a treatment recommendation for post-operative chemotherapy, on the basis of the participant's response to pre-operative treatment with paclitaxel, trastuzumab, and pertuzumab.
In addition, the investigators are evaluating how the body's immune system works with paclitaxel, trastuzumab, and pertuzumab to kill cancer cells. For this reason, the investigators will collect samples of the participant's breast tumor and samples of the participant's blood over time to understand the reaction of the immune system to the participant's tumor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||DAPHNe: De-escalation to Adjuvant Antibodies Post-pCR to Neoadjuvant THP (Paclitaxel/Trastuzumab/Pertuzumab)—a Pilot Study in HER2-positive Breast Cancer|
|Actual Study Start Date :||November 5, 2018|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||September 1, 2030|
Paclitaxel is administered intravenously on days 1, 8, and 15 of each 21-day cycle Trastuzumab is administered intravenously on day 1 of each 21-day cycle Pertuzumab is administered intravenously on Day 1 of each 21-day cycle
Paclitaxel is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug
Other Name: Taxol
Trastuzumab works by targeting the HER2/neu receptor on cancer cells
Other Name: Herceptin
Pertuzumab is a monoclonal antibody which targets the surface of the cells human epidermal growth factor receptor 2 protein (HER2) on the cancer cell, interfering with HER2 causing cancer cell death
Other Name: Perjeta
- Adjuvant chemotherapy Received [ Time Frame: 2.5 years ]To assess adherence to protocol-specified antibody doublet therapy in the adjuvant setting among patients with stage II-III HER2+ breast cancer who achieve pathologic complete response (pCR) following neoadjuvant Paclitaxel/Trastuzumab/Pertuzumab (THP).
- pCR rate [ Time Frame: 2 years ]To assess pathologic complete response (pCR) for 1) all patients, 2) hormone receptor positive (HR+) patients, and 3) hormone receptor negative (HR-) patients
- Residual Cancer Burden (RCB) scores [ Time Frame: 2 years ]To assess residual cancer burden (RCB) in 1) all patients, 2) hormone receptor positive patients (HR+), 3) hormone receptor negative (HR-) patients. RCB is scored from 0 to 3, (with possible values 0, 1, 2, 3), where 0 is the best score and indicates eradication of all disease at the time of surgery, and 3 is the worst score, indicating poor response to preoperative therapy.
- Reasons for Off-Protocol Escalation per study-specific questionnaires [ Time Frame: 2 years ]Patients and physicians will complete questionnaires to assess reasons for off-protocol escalation (meaning, a decision to administer post-operative chemotherapy, for patients with pCR). Standardized questionnaires for both patients and physician reviewers have been developed specifically for this study. Responses are qualitative and do not involve a scale.
- Reasons for Off-Protocol De-Escalation per study-specific questionnaires [ Time Frame: 2 years ]Patients and physicians will complete questionnaires to assess reasons for off-protocol de-escalation (meaning, a decision not to administer post-operative chemotherapy, for patients without pCR). Standardized questionnaires for both patients and physician reviewers have been developed specifically for this study. Responses are qualitative and do not involve a scale.
- One Year of Trastuzumab and Pertuzumab [ Time Frame: 3 years ]To assess the percentage of patients completing one year of HP
- Event-Free Survival (EFS) [ Time Frame: 12 years ]To measure event-free survival (EFS), and to compare EFS in the following subgroups: 1) Patients with pCR versus patients without pCR; 2) Patients with RCB 0 or 1, versus patients with RCB 2 or 3
- Recurrence-Free Interval (RFI) [ Time Frame: 12 years ]To measure recurrence-free interval (RFI), and to compare RFI in the following subgroups: 1) Patients with pCR versus patients without pCR; 2) Patients with RCB 0 or 1, versus patients with RCB 2 or 3
- Overall survival (OS) [ Time Frame: 12 years ]To measure overall survival (OS) as an exploratory endpoint
- Post-THP (Paclitaxel/Trastuzumab/Pertuzumab) imaging findings and pathology findings in the surgical specimen [ Time Frame: 2 years ]To evaluate correlation between post-THP (Paclitaxel/Trastuzumab/Pertuzumab) imaging findings and pathology findings in the surgical specimen
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): NCT03716180
|Contact: Adrienne G Waks, MDemail@example.com|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Laura Spring, MD firstname.lastname@example.org|
|Beth Israel Deaconess Medical Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Neelam Desai, MD 617-667-7081 email@example.com|
|Principal Investigator: Neelam Desai, MD|
|Dana-Farber Cancer Institute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Adrienne G Waks, MD 617-632-3800 firstname.lastname@example.org|
|Principal Investigator: Adrienne G Waks, MD|
|DF/BWCC at Milford Regional Medical Center||Recruiting|
|Milford, Massachusetts, United States, 01757|
|Contact: Michael Constantine, MD email@example.com|
|DF/BWCC in clinical affiliation with South Shore Hospital||Recruiting|
|South Weymouth, Massachusetts, United States, 02190|
|Contact: Meredith Faggen, MD firstname.lastname@example.org|
|Principal Investigator:||Adrienne G Waks, MD||Dana-Farber Cancer Institute|