Breast CancerPhase 2PANDoRANCT03872505
Pre-operAtive Non-Anthracycline Chemotherapy, Durvalumab +/- RAdiation Therapy in Triple Negative Breast Cancer
A Phase 2 study testing Durvalumab, Radiation Therapy and Carboplatin in people with Breast Cancer and Triple Negative Breast Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
This phase II randomized trial is for patients with clinical stage II-III, ER and PR <10%, HER2-negative invasive breast carcinoma (triple negative breast cancer) for whom adjuvant RT is planned and pre-operative RT is deemed feasible by the treating radiation oncologist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Triple Negative Breast Cancer
- What is being tested?
- Durvalumab, Radiation Therapy and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2022to Jul 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male/female patients with histologically confirmed invasive breast cancer, ER <10%, PR <10% and HER2-negative for whom adjuvant RT is planned and in whom pre-operative RT is feasible.
- Clinical stage II-III by the AJCC 8th definition, any nodal status (cT2-4N0 or cT1-4N1-3), biopsies of clinically suspicious lymph nodes to confirm nodal status is encouraged.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- At least 18 years of age on the day of signing informed consent.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Body weight >30kg.
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- Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Have adequate organ function as defined in the following table (Table 1). Specimens must be collected within 10 days prior to the start of study treatment.
- Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Patients with multifocal, multicentric or bilateral breast cancer are permitted if all suspicious foci have been biopsied and deemed "triple negative" per criterion 1.
- Male participants:
- A male participant must agree to use a contraception as detailed in Appendix C of this protocol during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period.
- Female participants:
- A female participant is eligible to participate if she is not pregnant (see Appendix C), not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in Appendix C OR
- A WOCBP who agrees to follow the contraceptive guidance in Appendix C during the treatment period and for at least 6 months after the last dose of study treatment.
Who cannot join
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization (see Appendix C). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Major surgical procedure within 28 days prior to the first dose of study drug.
- History of allogenic organ transplantation.
- Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Note: Patients, if enrolled, should not receive live vaccine whilst receiving IP and up to 30 days after the last dose of IP.
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- Participation in another clinical study with an investigational product during the last 4 weeks, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
- History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- Adequately treated carcinoma in situ without evidence of disease
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
- Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia
- Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Any chronic skin condition that does not require systemic therapy
- Patients without active disease in the last 5 years may be included but only after consultation with the study physician
- Patients with celiac disease controlled by diet alone
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Has an active infection requiring systemic therapy.
- History of active primary immunodeficiency.
- Known active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B, hepatitis C, or human immunodeficiency virus . Patients with a past or resolved HBV infection are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab monotherapy.
- Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment.
- Stage IV (metastatic) breast cancer
- Inflammatory breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: A Randomized Phase II Study Evaluating Pathologic Response Rates Following Pre-operAtive Non-Anthracycline Chemotherapy, Durvalumab (MEDI4736) +/- RAdiation Therapy (RT) in Triple Negative Breast Cancer (TNBC): The PANDoRA Study.
This phase II randomized trial is for patients with clinical stage II-III, ER and PR <10%, HER2-negative invasive breast carcinoma (triple negative breast cancer) for whom adjuvant RT is planned and pre-operative RT is deemed feasible by the treating radiation oncologist. Subjects will be randomized into arm A or B and treatment will last for 16 weeks. Both groups will receive Durvalumab 750mg IV Q2 weeks x 2 then a biopsy prior to durvalumab 1500mg IV Q4 weeks x 3 with paclitaxel and carboplatin IV weekly x 12. Arm B will receive radiation (24 Gy total) starting with the second durvalumab dose every other day (8Gy per fraction) for one week. Following treatment, subjects will receive SOC breast surgery and continue on to physician's choices SOC treatment during the 3 year follow up period.
This study hopes to explore the impact of checkpoint blockade administration with a non- anthracycline chemotherapy regimen plus RT on post-surgery pathologic complete response (pCR) rate in the breast and axilla (ypT0/Tis ypN0) following 12 weeks of treatment and surgery.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Being tested
- Durvalumab, Radiation Therapy, Carboplatin, Paclitaxel
- Keywords
- breast cancer, durvalumab, immunotherapy, triple negative, HER2 negative, ER/PR negative, carboplatin, radiation therapy, paclitaxel, neoadjuvant, stage II breast cancer, stage III breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DurvalumabDrug
Also called Imfimzi
IV administration of 5 treatments;every 2 weeks for 2 treatments and then every 4 weeks for 3 treatments
Radiation TherapyRadiation
The second dose of durvalumab will be given in conjunction with an RT boost, consisting of 8 Gy in 3 fractions for a total of 24 Gy.
CarboplatinDrug
IV administration weekly for 12 weeks
PaclitaxelDrug
IV administration every week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy + Durvalumab | Active comparator | Arm A: Carboplatin, Paclitaxel and Durvalumab Receives: Drug: Durvalumab; Drug: Carboplatin; Drug: Paclitaxel |
| Chemo + Durvalumab + Radiation Therapy | Experimental | Arm B: Carboplatin, Paclitaxel and Durvalumab + Radiation Therapy Receives: Drug: Durvalumab; Radiation: Radiation Therapy; Drug: Carboplatin; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate in the breast and axilla
Proportion of subjects without residual invasive cancer in the breast and axilla from randomization to definitive surgery.
Measured as the lack of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy at the time of definitive surgery.
Measured: 20 weeks from randomization
Secondary outcomes (8)
Pathological complete invasive and in situ response rate (breast and axilla)
Proportion of subjects without residual invasive and in situ cancer in the breast and axilla disease from randomization to definitive surgery.
- Residual invasive cancer and in situ disease defined based on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by pathological assessment.
Measured: 20 weeks from randomization
Proportion of subjects with pathological invasive complete response in the breast only
Proportion of subjects without residual invasive cancer in the breast from randomization to definitive surgery.
- Residual invasive breast cancer defined based on hematoxylin and eosin evaluation of the complete resected breast specimen following completion of neoadjuvant systemic therapy by pathological assessment.
Measured: 20 weeks from randomization
Residual Cancer Burden (RCB)
Proportion of subjects with RCB 0-I, II or III from randomization to definitive surgery.
-Residual Cancer Burden defined based on the RCB index, a component of four pathological parameters: bi-dimensional diameter of primary tumor bed, percent of cellularity in the tumor bed, number of involved lymph nodes and size of the largest nodal metastasis. The RCB possible scores are: RCB 0 (pCR), RCB I, RCB II, RCB III.
Measured: 20 weeks from randomization
Event Free Survival
Mean difference in time (in months) from randomization to any of the following events progression of disease that precludes surgery, local or distant recurrence, or death due to any cause.
Measured: 36 months from randomization
Invasive disease-free survival (IDFS)
Mean difference in time (in months) from date of surgery (date of no disease) to the first documentation of invasive progressive disease or death.
Measured: 33 months from surgery
Overall survival
Mean difference in time (in months) from randomization to death.
Measured: 36 months from randomization
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and severity of adverse events (AE) and serious adverse events (SAE) from cycle 1 day 1 until 30 days post-surgery.
-AEs and SAEs based on CTCAE 5.0
Measured: 24 weeks from treatment initiation
Frequency of adjuvant treatment after surgery
Average number of subjects receiving adjuvant treatment after surgery.
Measured: 36 months from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study startJul 2022 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2027 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Heather McArthur, MD, MPH, Principal investigator, Cedars-Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872505
- Sponsor's protocol ID
- IIT2018-17-McArthur-TCDRT
- Acronym
- PANDoRA
- Status last verified
- Aug 2021
- First submitted
- 11 Mar 2019
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study Evaluating Pathologic Response Rates Following Pre-operAtive Non-Anthracycline Chemotherapy, Durvalumab (MEDI4736) +/- RAdiation Therapy (RT) in Triple Negative Breast Cancer (TNBC): The PANDoRA Study.
- ClinicalTrials.gov ID
- NCT03872505
- Acronym / sponsor ID
- PANDoRA / IIT2018-17-McArthur-TCDRT
- Conditions
- Breast Cancer, Triple Negative Breast Cancer
- Keywords
- breast cancer, durvalumab, immunotherapy, triple negative, HER2 negative, ER/PR negative, carboplatin, radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 13 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II randomized trial is for patients with clinical stage II-III, ER and PR <10%, HER2-negative invasive breast carcinoma (triple negative breast cancer) for whom adjuvant RT is planned and pre-operative RT is deemed feasible by the treating radiation oncologist. Subjects will be randomized into arm A or B and treatment will last for 16 weeks. Both groups will receive Durvalumab 750mg IV Q2 weeks x 2 then a biopsy prior to durvalumab 1500mg IV Q4 weeks x 3 with paclitaxel and carboplatin IV weekly x 12. Arm B will receive radiation (24 Gy total) starting with the second durvalumab dose every other day (8Gy per fraction) for one week. Following treatment, subjects will receive SOC breast surgery and continue on to physician's choices SOC treatment during the 3 year follow up period.
This study hopes to explore the impact of checkpoint blockade administration with a non- anthracycline chemotherapy regimen plus RT on post-surgery pathologic complete response (pCR) rate in the breast and axilla (ypT0/Tis ypN0) following 12 weeks of treatment and surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy + Durvalumab | Active comparator | Drug: Durvalumab, Drug: Carboplatin, Drug: PaclitaxelArm A: Carboplatin, Paclitaxel and Durvalumab |
| Chemo + Durvalumab + Radiation Therapy | Experimental | Drug: Durvalumab, Radiation: Radiation Therapy, Drug: Carboplatin, Drug: PaclitaxelArm B: Carboplatin, Paclitaxel and Durvalumab + Radiation Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male/female patients with histologically confirmed invasive breast cancer, ER <10%, PR <10% and HER2-negative for whom adjuvant RT is planned and in whom pre-operative RT is feasible.
- Clinical stage II-III by the AJCC 8th definition, any nodal status (cT2-4N0 or cT1-4N1-3), biopsies of clinically suspicious lymph nodes to confirm nodal status is encouraged.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol. Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
- At least 18 years of age on the day of signing informed consent.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
Key exclusion criteria (31 listed)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization (see Appendix C). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
- Major surgical procedure within 28 days prior to the first dose of study drug.
- History of allogenic organ transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DurvalumabAlso: ImfimziIV administration of 5 treatments;every 2 weeks for 2 treatments and then every 4 weeks for 3 treatments | Drug | Chemo + Durvalumab + Radiation Therapy, Chemotherapy + Durvalumab |
| Radiation TherapyThe second dose of durvalumab will be given in conjunction with an RT boost, consisting of 8 Gy in 3 fractions for a total of 24 Gy. | Radiation | Chemo + Durvalumab + Radiation Therapy |
| CarboplatinIV administration weekly for 12 weeks | Drug | Chemo + Durvalumab + Radiation Therapy, Chemotherapy + Durvalumab |
| PaclitaxelIV administration every week for 12 weeks | Drug | Chemo + Durvalumab + Radiation Therapy, Chemotherapy + Durvalumab |
Primary outcome
Pathological complete response rate in the breast and axilla
Time frame: 20 weeks from randomization
Proportion of subjects without residual invasive cancer in the breast and axilla from randomization to definitive surgery. Measured as the lack of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy at the time of definitive surgery.
8 secondary outcomes
Pathological complete invasive and in situ response rate (breast and axilla)
Time frame: 20 weeks from randomization
Proportion of subjects with pathological invasive complete response in the breast only
Time frame: 20 weeks from randomization
Residual Cancer Burden (RCB)
Time frame: 20 weeks from randomization
Event Free Survival
Time frame: 36 months from randomization
Invasive disease-free survival (IDFS)
Time frame: 33 months from surgery
Overall survival
Time frame: 36 months from randomization
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 24 weeks from treatment initiation
Frequency of adjuvant treatment after surgery
Time frame: 36 months from randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather McArthur, MD, MPH principal investigator
Cedars-Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab, Radiation Therapy and Carboplatin in people with Breast Cancer and Triple Negative Breast Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate in the breast and axilla (time frame: 20 weeks from randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.