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Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS)

Palbociclib and Endocrine Therapy for LObular Breast Cancer Preoperative Study (PELOPS): A Randomized Phase II Study of Palbociclib With Letrozole Versus Letrozole Alone for Invasive Lobular Carcinoma and Invasive Ductal Carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02764541
Enrollment
195
Registered
2016-05-06
Start date
2016-05-24
Completion date
2031-04-01
Last updated
2026-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Invasive Lobular Carcinoma

Brief summary

This research study is evaluating how well Breast Cancer responds to preoperative treatment with Endocrine treatment in combination with a drug called Palbociclib or Endocrine treatment alone as possible treatments for Hormone Receptor Positive Breast Cancer.

Detailed description

This is an open label phase II neoadjuvant clinical trial of Palbociclib in combination with endocrine therapy for hormone receptor positive early-stage breast cancer. The planned sample size is 180 participants. The study includes a "window treatment" phase followed by a treatment phase. In the window phase, participants will be treated with a two-week course of tamoxifen (Arm A) or letrozole (Arm B). In the treatment phase participants will be randomized to receive endocrine therapy in combination with palbociclib (Arm C) or endocrine therapy alone (Arm D) for a total duration of 24 weeks. Premenopausal patients with either invasive lobular or ductal carcinoma will be eligible to enroll directly into the treatment phase of the study. The study has two co-primary objectives: 1) To evaluate the difference in anti-proliferative activity of letrozole versus tamoxifen measured by changes in Ki67 from baseline to research biopsy (day 15) within cohorts of hormone receptor positive breast cancer for patients with invasive lobular and ductal carcinoma. 2) To evaluate the pathologic complete response (pCR) of endocrine therapy plus palbociclib and of endocrine therapy alone in breast cancer patients diagnosed with hormone receptor positive invasive breast cancer.

Interventions

DRUGLetrozole
DRUGTamoxifen
DRUGPalbociclib
DRUGEndocrine Therapy

Sponsors

Dana-Farber Cancer Institute
Lead SponsorOTHER
Pfizer
CollaboratorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients must have Stage I to III histologically confirmed invasive carcinoma of the breast. A minimum tumor size of at least 1.5 cm determined by physical exam or imaging (whichever is larger) is required. * Patients must have histologically confirmed hormone receptor positive (ER and/or PR), HER2 negative, invasive breast cancer. ER, PR and HER2 measurements should be performed according to institutional guidelines, in a CLIA-approved setting in the US or certified laboratories for Non-US regions. Cut-off values for positive/negative staining should be in accordance with current ASCO/CAP (American Society of Clinical Oncology/College of American Pathologists) guidelines. Central confirmation is not required for ER, PR, or HER statuses. * Patients with equivocal HER2 in situ hybridization results according to current ASCO/CAP guidelines are allowed, as long as the clinician has determined that they should be treated as HER2 negative. * For the window phase: Patients must have histologically confirmed invasive lobular carcinoma or invasive ductal carcinoma. No central confirmation of histological subtype is necessary for enrollment. * For the treatment phase: Patients with any histological subtype are eligible. * Women 18 years of age. Men are not eligible. * ECOG performance status 0 or 1 * Required laboratory values: * Absolute neutrophil count ≥ 1,500/mm3 * Platelets ≥ 100,000/mm3 * Hemoglobin ≥ 10g/dL * Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome * Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) ≤ 2.0 × institutional ULN * Serum creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN * Postmenopausal patients defined as no spontaneous menses ≥1 year (12 months) or post bilateral surgical oophorectomy. Premenopausal patients are eligible to participate provided they are considered in chemical menopause. Premenopausal patients should receive ongoing treatment with LHRH agonists (goserolin or leuprolide). Premenopausal patients must be enrolled directly into the treatment phase of the study. * Patient must agree to the required research biopsies at baseline and after the two-week treatment with endocrine therapy in the initial part of the study ("window phase"); or at baseline and after two-week treated with endocrine therapy plus or minus palbociclib for those patients enrolled directly into the treatment phase of the study. * Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption. * Breast imaging should include imaging of the ipsilateral axilla. For subjects with a clinically negative axilla, a sentinel lymph node biopsy will be performed either before or after preoperative therapy at the discretion of the subject's physicians. For subjects with a clinically positive axilla, a needle aspiration, core biopsy or SLN procedure will be performed to determine the presence of metastatic disease in the lymph nodes. * Patients with multifocal or multicentric disease are eligible if the treating clinician has determined the patient should be treated as ER+ and HER2- negative. * Bilateral breast cancers are allowed if the treating clinician has determined the patient should be treated as ER+ and HER2- negative. * Serum or urine pregnancy test must be negative in women judged premenopausal within 7 days of randomization, or in women with amenorrhea of less than 12 months at time of randomization. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before randomization, as determined by local practice, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. * Premenopausal patients must agree to use adequate contraception for the duration of protocol treatment and for 6 months after the last treatment with palbociclib. Adequate contraception is defined as one highly effective form (i.e. abstinence, male or female sterilization) OR two effective forms (e.g. non-hormonal IUD and condom/occlusive cap with spermicidal foam / gel / film / cream/ suppository). Hormonal contraceptive methods are not allowed. * Patients with a history of ipsilateral or contralateral DCIS are eligible. * Patients may concurrently receive bisphosphonates or rank ligand inhibitors while on this study if necessary for treatment or prevention of osteopenia or osteoporosis. Prior treatment with LHRH agonists is allowed for premenopausal women. Topical vaginal estrogen therapy is allowable. * Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

* Concurrent therapy with other Investigational Products. * Prior therapy with any CDK inhibitor. * Patients with Stage IV breast cancer are not eligible. Baseline staging to document absence of metastatic disease is not required, however is recommended as determined by institutional practice (in patients where there may be a reasonable suspicion of advanced disease e.g., large tumors, clinically positive axillary lymph nodes, signs and symptoms). If performed, reports of these examinations must be available. Examination type for staging, i.e. X-ray, sonography, bone scans, CT, MRI, and/or PET-CT, is at the discretion of the investigator. * History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib. * Patients receiving any medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization * Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social situations that would limit compliance with study requirements. Ability to comply with study requirements is to be assessed by each investigator at the time of screening for study participation. * Pregnant women, or women of childbearing potential without a negative pregnancy test (serum or urine) within 7 days prior to randomization, irrespective of the method of contraception used, are excluded from this study because the effect of palbociclib on a developing fetus is unknown. Breastfeeding must be discontinued prior to study entry. * Patients with a history of any malignancy are ineligible except for the following circumstances: * Patients with a malignancy history other than invasive breast cancer are eligible if they have no active malignancy and are deemed by the investigator to be at low risk for recurrence of that malignancy. * Patients with the following cancers are eligible: ductal carcinoma in situ of the breast, cervical cancer in situ, and non-metastatic non-melanomatous skin cancers. * Patients on combination antiretroviral therapy, i.e. those who are HIV-positive, are ineligible because of the potential for pharmacokinetic interactions or increased immunosuppression with palbociclib. HIV testing is not required, but patients must not be known to be HIV-positive. * Patients receiving concurrent exogenous hormone therapy (hormone replacement therapy, oral or any other hormonal contraceptives such as hormonal contraceptive coil are not eligible. * Patients are not eligible if they have previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy. This includes use for prophylactic reasons, including treatment of osteoporosis or cancer prevention with tamoxifen, raloxifene, or AI.

Design outcomes

Primary

MeasureTime frameDescription
Difference in Anti-proliferative Activity of Patients Given Letrozole Versus Tamoxifen During the Window Phasebaseline to day 15Log fold change in anti-proliferative activity of Letrozole versus Tamoxifen within cohorts of hormone receptor positive breast cancer for patients with invasive lobular and ductal carcinoma during the window phase. Higher absolute value indicates larger change in the anti-proliferative activity
Pathologic Complete Response (pCR) of Patients Given Endocrine Therapy Plus Palbociclib and of Endocrine Therapy Alone During the Treatment Phaseday 15 to 24 weeksResidual Cancer Burden index (RCB) between hormone receptor positive invasive breast cancer patients given endocrine therapy plus palbociclib (Arm C) and endocrine therapy alone (Arm D). RCB score is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to infinity. Higher RCB score indicates more tumor burden remaining, thus worse outcome.

Secondary

MeasureTime frameDescription
Odds Ratio of Achieving Cell Cycle Arrest at the End of Window Phasebaseline to day 15Odds Ratio of Achieving Cell Cycle Arrest at the end of Window Phase in hormone receptor positive invasive breast cancer patients given Tamoxifen vs Letrozole. Cell cycle arrest is defined to be percentage of Ki67\<2.7
Change in RCB Index Between Arm C and Arm D During the Treatment Phaseday 15 to 24 weeksThe estimate of RCB index change for patients who receive both endocrine and Palbociclib instead of endocrine alone, but have the same lymph node status, tumor size and menopausal status. RCB score is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to infinity. Higher RCB score indicates more tumor burden remaining, thus worse outcome.
Number of Participants With RCB Response in Arm C and Arm D During the Treatment Phaseday 15 to 24 weeksRCB response is defined as RCB-0 or RCB-I; RCB not response is defined as RCB-II or RCB-III Residual Cancer Burden (RCB) considers residual disease in the tumor bed and lymph nodes after NAC, generating a continuous score which is then grouped into four categories: RCB-0, RCB-I, RCB-II and RCB-III. Higher RCB group reflects more tumor burden remaining, thus worse outcome
Percentage of Participants With Clinical Response in Arm C and Arm D in the Treatment Phaseday 15 to 24 weeksPercentage of Participants with Clinical Response in Arm C and Arm D in Breast cancer patients diagnosed with hormone receptor positive invasive breast cancer; Clinical response rate is defined as the number of partial and complete responses after preoperative endocrine therapy plus palbociclib (Arm C) and of endocrine therapy alone (Arm D)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOROtto Metzger, MD

Dana-Farber Cancer Institute

Participant flow

Pre-assignment details

Three patients withdrew consent before receiving intervention

Participants by arm

ArmCount
Arm A Tamoxifen First, Then Arm C Endocrine With Palbociclib
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks.
36
Arm A Tamoxifen First, Then Arm D Endocrine Alone
Tamoxifen is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks.
21
Arm B Letrozole First, Then Arm C Endocrine With Palbociclib
Letrozole is given in the window phase for 2 weeks; Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks.
37
Arm B Letrozole First, Then Arm D Endocrine Alone
Letrozole is given in the window phase for 2 weeks; Endocrine therapy alone is given in the treatment phase for 24 weeks.
19
Arm A Tamoxifen Only
Tamoxifen is given in the window phase for 2 weeks
1
Arm B Letrozole Only
Letrozole is given in the window phase for 2 weeks
2
Arm C Endocrine With Palbociclib Only
Endocrine therapy in combination with Palbociclib are given in the treatment phase for 24 weeks
55
Arm D Endocrine Alone Only
Endocrine therapy alone is given in the treatment phase for 24 weeks
21
Total192

Baseline characteristics

CharacteristicArm A Tamoxifen First, Then Arm C Endocrine With PalbociclibArm D Endocrine Alone OnlyArm C Endocrine With Palbociclib OnlyArm B Letrozole OnlyArm A Tamoxifen OnlyTotalArm B Letrozole First, Then Arm D Endocrine AloneArm A Tamoxifen First, Then Arm D Endocrine AloneArm B Letrozole First, Then Arm C Endocrine With Palbociclib
Age, Continuous64.0 years48.0 years49.0 years62.0 years56.0 years57.0 years65.0 years62.0 years64.0 years
Baseline clinical N stage
N0
19 Participants12 Participants28 Participants2 Participants1 Participants102 Participants10 Participants11 Participants19 Participants
Baseline clinical N stage
N1
17 Participants9 Participants21 Participants0 Participants0 Participants81 Participants8 Participants9 Participants17 Participants
Baseline clinical N stage
N2
0 Participants0 Participants1 Participants0 Participants0 Participants3 Participants0 Participants1 Participants1 Participants
Baseline clinical N stage
N3
0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants
Baseline clinical N stage
Unknown
0 Participants0 Participants4 Participants0 Participants0 Participants5 Participants1 Participants0 Participants0 Participants
Baseline clinical T stage
T1a
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants1 Participants0 Participants
Baseline clinical T stage
T1b
0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants
Baseline clinical T stage
T1c
6 Participants2 Participants3 Participants0 Participants0 Participants17 Participants2 Participants2 Participants2 Participants
Baseline clinical T stage
T2
20 Participants11 Participants34 Participants2 Participants1 Participants114 Participants13 Participants12 Participants21 Participants
Baseline clinical T stage
T3
8 Participants8 Participants15 Participants0 Participants0 Participants52 Participants4 Participants5 Participants12 Participants
Baseline clinical T stage
T4
2 Participants0 Participants1 Participants0 Participants0 Participants5 Participants0 Participants0 Participants2 Participants
Baseline clinical T stage
Unknown
0 Participants0 Participants1 Participants0 Participants0 Participants2 Participants0 Participants1 Participants0 Participants
Baseline Histology
Both
1 Participants2 Participants7 Participants0 Participants1 Participants15 Participants0 Participants3 Participants1 Participants
Baseline Histology
Invasive Ductal
14 Participants9 Participants29 Participants0 Participants0 Participants92 Participants10 Participants11 Participants19 Participants
Baseline Histology
Invasive Lobular
21 Participants9 Participants19 Participants2 Participants0 Participants84 Participants9 Participants7 Participants17 Participants
Baseline Histology
Other
0 Participants1 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants
Baseline Invasive Primary Breast Cancer Stage
I
4 Participants0 Participants6 Participants0 Participants0 Participants15 Participants1 Participants2 Participants2 Participants
Baseline Invasive Primary Breast Cancer Stage
II
26 Participants19 Participants44 Participants2 Participants1 Participants154 Participants18 Participants17 Participants27 Participants
Baseline Invasive Primary Breast Cancer Stage
III
6 Participants2 Participants5 Participants0 Participants0 Participants23 Participants0 Participants2 Participants8 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants2 Participants3 Participants0 Participants0 Participants8 Participants1 Participants1 Participants1 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
33 Participants19 Participants48 Participants2 Participants1 Participants172 Participants17 Participants19 Participants33 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants0 Participants4 Participants0 Participants0 Participants12 Participants1 Participants1 Participants3 Participants
Menopausal Status
Post-menopausal
35 Participants0 Participants8 Participants2 Participants1 Participants123 Participants19 Participants21 Participants37 Participants
Menopausal Status
Pre-menopausal
1 Participants21 Participants47 Participants0 Participants0 Participants69 Participants0 Participants0 Participants0 Participants
Race
Asian
0 Participants0 Participants2 Participants0 Participants0 Participants3 Participants0 Participants0 Participants1 Participants
Race
Black or African American
5 Participants2 Participants3 Participants0 Participants0 Participants11 Participants0 Participants0 Participants1 Participants
Race
More than one race
0 Participants2 Participants2 Participants0 Participants0 Participants7 Participants1 Participants1 Participants1 Participants
Race
Other
0 Participants0 Participants1 Participants0 Participants0 Participants2 Participants0 Participants0 Participants1 Participants
Race
White
31 Participants17 Participants47 Participants2 Participants1 Participants169 Participants18 Participants20 Participants33 Participants
Sex: Female, Male
Female
36 Participants21 Participants55 Participants2 Participants1 Participants192 Participants19 Participants21 Participants37 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Surgery Type
Breast Conservation/Lumpectomy
17 Participants5 Participants21 Participants0 Participants0 Participants85 Participants12 Participants10 Participants20 Participants
Surgery Type
Mastectomy
17 Participants13 Participants31 Participants0 Participants0 Participants93 Participants5 Participants10 Participants17 Participants
Surgery Type
Missing
2 Participants3 Participants3 Participants2 Participants1 Participants14 Participants2 Participants1 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
deaths
Total, all-cause mortality
1 / 362 / 210 / 371 / 190 / 10 / 23 / 551 / 21
other
Total, other adverse events
36 / 3621 / 2137 / 3718 / 190 / 11 / 255 / 5519 / 21
serious
Total, serious adverse events
3 / 363 / 2114 / 370 / 190 / 10 / 221 / 550 / 21

Outcome results

Primary

Difference in Anti-proliferative Activity of Patients Given Letrozole Versus Tamoxifen During the Window Phase

Log fold change in anti-proliferative activity of Letrozole versus Tamoxifen within cohorts of hormone receptor positive breast cancer for patients with invasive lobular and ductal carcinoma during the window phase. Higher absolute value indicates larger change in the anti-proliferative activity

Time frame: baseline to day 15

Population: Patients both not missing baseline and day15 Ki67 were included into the analysis population

ArmMeasureValue (MEAN)Dispersion
Tamoxifen With Invasive DuctalDifference in Anti-proliferative Activity of Patients Given Letrozole Versus Tamoxifen During the Window Phase-0.180 log fold-changeStandard Deviation 2.5
Letrozole With Invasive DuctalDifference in Anti-proliferative Activity of Patients Given Letrozole Versus Tamoxifen During the Window Phase-1.304 log fold-changeStandard Deviation 2.2
Tamoxifen With Invasive LobularDifference in Anti-proliferative Activity of Patients Given Letrozole Versus Tamoxifen During the Window Phase-0.635 log fold-changeStandard Deviation 2.5
Letrozole With Invasive LobularDifference in Anti-proliferative Activity of Patients Given Letrozole Versus Tamoxifen During the Window Phase-1.944 log fold-changeStandard Deviation 2.6
p-value: 0.0045Wilcoxon (Mann-Whitney)
p-value: 0.0161Wilcoxon (Mann-Whitney)
Primary

Pathologic Complete Response (pCR) of Patients Given Endocrine Therapy Plus Palbociclib and of Endocrine Therapy Alone During the Treatment Phase

Residual Cancer Burden index (RCB) between hormone receptor positive invasive breast cancer patients given endocrine therapy plus palbociclib (Arm C) and endocrine therapy alone (Arm D). RCB score is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to infinity. Higher RCB score indicates more tumor burden remaining, thus worse outcome.

Time frame: day 15 to 24 weeks

Population: Patients with treatment and surgery are included into the analysis population

ArmMeasureValue (MEAN)
Tamoxifen With Invasive DuctalPathologic Complete Response (pCR) of Patients Given Endocrine Therapy Plus Palbociclib and of Endocrine Therapy Alone During the Treatment Phase2.88 score on a scale
Letrozole With Invasive DuctalPathologic Complete Response (pCR) of Patients Given Endocrine Therapy Plus Palbociclib and of Endocrine Therapy Alone During the Treatment Phase2.88 score on a scale
p-value: 0.9288Wilcoxon (Mann-Whitney)
Secondary

Change in RCB Index Between Arm C and Arm D During the Treatment Phase

The estimate of RCB index change for patients who receive both endocrine and Palbociclib instead of endocrine alone, but have the same lymph node status, tumor size and menopausal status. RCB score is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to infinity. Higher RCB score indicates more tumor burden remaining, thus worse outcome.

Time frame: day 15 to 24 weeks

Population: Patients with treatment and surgery are included into the analysis population

ArmMeasureValue (MEAN)
Tamoxifen With Invasive DuctalChange in RCB Index Between Arm C and Arm D During the Treatment Phase2.88 units on a scale
Letrozole With Invasive DuctalChange in RCB Index Between Arm C and Arm D During the Treatment Phase2.88 units on a scale
p-value: 0.9295% CI: [-0.29, 0.32]Regression, Linear
Secondary

Number of Participants With RCB Response in Arm C and Arm D During the Treatment Phase

RCB response is defined as RCB-0 or RCB-I; RCB not response is defined as RCB-II or RCB-III Residual Cancer Burden (RCB) considers residual disease in the tumor bed and lymph nodes after NAC, generating a continuous score which is then grouped into four categories: RCB-0, RCB-I, RCB-II and RCB-III. Higher RCB group reflects more tumor burden remaining, thus worse outcome

Time frame: day 15 to 24 weeks

Population: Patients with treatment and surgery are included into the analysis population

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Tamoxifen With Invasive DuctalNumber of Participants With RCB Response in Arm C and Arm D During the Treatment Phase10 Participants
Letrozole With Invasive DuctalNumber of Participants With RCB Response in Arm C and Arm D During the Treatment Phase3 Participants
p-value: 0.758Fisher Exact
Secondary

Odds Ratio of Achieving Cell Cycle Arrest at the End of Window Phase

Odds Ratio of Achieving Cell Cycle Arrest at the end of Window Phase in hormone receptor positive invasive breast cancer patients given Tamoxifen vs Letrozole. Cell cycle arrest is defined to be percentage of Ki67\<2.7

Time frame: baseline to day 15

Population: Patients both not missing baseline and day15 Ki67 were included into the analysis population

ArmMeasureValue (NUMBER)
Tamoxifen With Invasive DuctalOdds Ratio of Achieving Cell Cycle Arrest at the End of Window Phase0.26 odds ratio
Letrozole With Invasive DuctalOdds Ratio of Achieving Cell Cycle Arrest at the End of Window Phase0.60 odds ratio
Secondary

Percentage of Participants With Clinical Response in Arm C and Arm D in the Treatment Phase

Percentage of Participants with Clinical Response in Arm C and Arm D in Breast cancer patients diagnosed with hormone receptor positive invasive breast cancer; Clinical response rate is defined as the number of partial and complete responses after preoperative endocrine therapy plus palbociclib (Arm C) and of endocrine therapy alone (Arm D)

Time frame: day 15 to 24 weeks

Population: Patients with treatment and surgery are included into the analysis population

ArmMeasureValue (NUMBER)
Tamoxifen With Invasive DuctalPercentage of Participants With Clinical Response in Arm C and Arm D in the Treatment Phase57.8 percentage of participants
Letrozole With Invasive DuctalPercentage of Participants With Clinical Response in Arm C and Arm D in the Treatment Phase43.3 percentage of participants

Source: ClinicalTrials.gov · Data processed: Jun 24, 2026